| FDA Device Classification |
Medical Specialty |
FDA Product Code |
FDA Regulation Number |
Device Class |
510k Exempt? |
| N-ACETYLPROCAINAMIDE CONTROL MATERIALS |
Clinical Toxicology |
LAZ |
862.3280 |
1 |
N |
| NAD REDUCTION (U.V.), PHOSPHOHEXOSE ISOMERASE |
Clinical Chemistry |
KLJ |
862.1570 |
1 |
Y |
| NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES |
Clinical Chemistry |
CGS |
862.1215 |
2 |
N |
| NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE |
Clinical Chemistry |
CFJ |
862.1440 |
2 |
Y |
| NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
Clinical Chemistry |
CKA |
862.1030 |
1 |
Y |
| NADH OXIDATION/NAD REDUCTION, AST/SGOT |
Clinical Chemistry |
CIT |
862.1100 |
2 |
N |
| NADH, PHOSPHOGLYCERATE MUTASE, ATP (U.V.) 2,3-DIPHOSPHOGLYCERIC ACID |
Clinical Chemistry |
JLZ |
862.1255 |
1 |
Y |
| NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD |
Clinical Toxicology |
DML |
862.3040 |
2 |
N |
| NADP REDUCTION (U.V.), GLUCOSE-6-PHOSPHATE DEHYDROGENASE |
Hematology |
JMC |
864.7360 |
2 |
N |
| NADP REDUCTION, 6-PHOSPHOGLUCONATE DEHYDROGENASE |
Clinical Chemistry |
JND |
862.1565 |
1 |
Y |
| NAIL, FIXATION, BONE |
Orthopedic |
JDS |
888.3030 |
2 |
N |
| NASAL FLOWMETER |
Ear, Nose, Throat |
ETL |
|
|
N |
| NASOGRAPH |
Ear, Nose, Throat |
ENL |
|
|
N |
| NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
Ear, Nose, Throat |
EOB |
874.4760 |
2 |
N |
| N-BENZOYL-L-ARGININE ETHYL ESTER (U.V.), TRYPSIN |
Clinical Chemistry |
JNO |
862.1725 |
1 |
Y |
| N-BENZOYL-L-TYROSINE ETHYL ESTER (U.V.), CHYMOTRYPSIN |
Clinical Chemistry |
JKX |
862.1180 |
1 |
Y |
| NEBULIZER (DIRECT PATIENT INTERFACE) |
Anesthesiology |
CAF |
868.5630 |
2 |
N |
| NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
Anesthesiology |
CCQ |
868.5640 |
1 |
Y |
| NEEDLE AND NEEDLE SET, GASTRO-UROLOGY, REPROCESSED |
Gastroenterology/Urology |
NMX |
876.1075 |
2 |
N |
| NEEDLE, ACUPUNCTURE, SINGLE USE |
General Hospital |
MQX |
880.5580 |
2 |
N |
| NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
General Plastic Surgery |
GAA |
878.4800 |
1 |
Y |
| NEEDLE, ASPIRATION AND INJECTION, REUSABLE |
General Plastic Surgery |
GDM |
878.4800 |
1 |
Y |
| NEEDLE, ASPIRATION AND NEEDLE, REPROCESSED |
General Plastic Surgery |
NNC |
878.4800 |
1 |
N |
| NEEDLE, ASPIRATION, OOCYTE, REPROCESSED |
Obstetrics/Gynecology |
NMO |
|
2 |
N |
| NEEDLE, ASSISTED REPRODUCTION |
Obstetrics/Gynecology |
MQE |
884.6100 |
2 |
N |
| NEEDLE, BIOPSY, CARDIOVASCULAR |
General Plastic Surgery |
DWO |
878.4800 |
1 |
Y |
| NEEDLE, BIOPSY, CARDIOVASCULAR, REPROCESSED |
General Plastic Surgery |
NLK |
878.4800 |
1 |
N |
| NEEDLE, CATHETER |
General Plastic Surgery |
GCB |
878.4200 |
1 |
Y |
| NEEDLE, CATHETER, REPROCESSED |
General Plastic Surgery |
NMT |
878.4200 |
1 |
N |
| NEEDLE, CERCLAGE, GYNECOLOGICAL |
Obstetrics/Gynecology |
HDH |
884.4530 |
1 |
Y |
| NEEDLE, CONDUCTION, ANESTHESIA, REPROCESSED |
Anesthesiology |
NNH |
868.5150 |
2 |
N |
| NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
Anesthesiology |
BSP |
868.5150 |
2 |
N |
| NEEDLE, DENTAL |
Dental |
DZM |
872.4730 |
1 |
Y |
| NEEDLE, DENTAL, REPROCESSED |
Dental |
NMW |
872.4730 |
1 |
N |
| NEEDLE, EMERGENCY AIRWAY |
Anesthesiology |
BWC |
868.5090 |
2 |
N |
| NEEDLE, ENDOSCOPIC |
Gastroenterology/Urology |
FBK |
876.1500 |
2 |
N |
| NEEDLE, ENDOSCOPIC, REPROCESSED |
Gastroenterology/Urology |
NMY |
876.1500 |
2 |
N |
| NEEDLE, FISTULA |
Gastroenterology/Urology |
FIE |
876.5540 |
1 |
Y |
| NEEDLE, FISTULA, REPROCESSED |
Gastroenterology/Urology |
NNE |
876.5540 |
2 |
N |
| NEEDLE, GASTRO-UROLOGY |
General Plastic Surgery |
FHR |
878.4800 |
1 |
Y |
| NEEDLE, GASTRO-UROLOGY, REPROCESSED |
General Plastic Surgery |
NMU |
878.4800 |
1 |
N |
| NEEDLE, HYPODERMIC, SINGLE LUMEN |
General Hospital |
FMI |
880.5570 |
2 |
N |
| NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED |
General Hospital |
NKK |
880.5570 |
2 |
N |
| NEEDLE, ISOTOPE, GOLD, TITANIUM, PLATINUM |
Radiology |
IWF |
892.5730 |
2 |
N |
| NEEDLE, ISOTOPE, REPROCESSED |
Radiology |
NMP |
892.5730 |
2 |
N |
| NEEDLE, NEUROSURGICAL SUTURE |
Neurology |
HAS |
882.4650 |
1 |
Y |
| NEEDLE, OPHTHALMIC SUTURING |
Opthalmic |
HNM |
886.4350 |
1 |
Y |
| NEEDLE, PHACOEMULSIFICATION, REPROCESSED |
Opthalmic |
NKX |
886.4670 |
2 |
N |
| NEEDLE, PNEUMOPERITONEUM, SIMPLE |
Gastroenterology/Urology |
FHP |
876.1500 |
2 |
N |
| NEEDLE, PNEUMOPERITONEUM, SPRING LOADED |
Gastroenterology/Urology |
FHO |
876.1500 |
2 |
N |
| NEEDLE, PNEUMOPERITONEUM, SPRING LOADED, REPROCESSED |
Gastroenterology/Urology |
NLX |
876.1500 |
2 |
N |
| NEEDLE, REPRODUCTION, ASSISTED, REPROCESSED |
Obstetrics/Gynecology |
NNB |
884.6100 |
2 |
N |
| NEEDLE, SPINAL, SHORT TERM |
Anesthesiology |
MIA |
868.5150 |
2 |
N |
| NEEDLE, SPINAL, SHORT TERM, REPROCESSED |
Anesthesiology |
NMR |
868.5150 |
2 |
N |
| NEEDLE, SUTURING, DISPOSABLE |
General Plastic Surgery |
GAB |
878.4800 |
1 |
Y |
| NEEDLE, SUTURING, REUSABLE |
General Plastic Surgery |
GDL |
878.4800 |
1 |
Y |
| NEEDLE, TONSIL SUTURING |
Ear, Nose, Throat |
KBR |
874.4420 |
1 |
Y |
| NEEDLE, TUMOR LOCALIZATION |
General Plastic Surgery |
MIJ |
878.4800 |
1 |
Y |
| NEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING |
General Hospital |
MWV |
|
|
N |
| NEISSERIA CONTROLS |
Microbiology |
LSC |
866.2660 |
1 |
Y |
| NEPHELOMETER |
Immunology |
JZW |
866.4540 |
1 |
Y |
| NEPHELOMETER, FOR CLINICAL USE |
Clinical Chemistry |
JQX |
862.2700 |
1 |
Y |
| NEPHELOMETRIC INHIBITION IMMUNOASSAY, DIPHENYLHYDANTOIN |
Clinical Toxicology |
LFO |
862.3350 |
2 |
N |
| NEPHELOMETRIC INHIBITION IMMUNOASSAY, PHENOBARBITAL |
Clinical Toxicology |
LFN |
862.3660 |
2 |
N |
| NEPHELOMETRIC METHOD, GLOBULIN |
Clinical Chemistry |
JGD |
862.1330 |
1 |
Y |
| NEPHELOMETRIC METHOD, LIPOPROTEINS |
Clinical Chemistry |
JHQ |
862.1475 |
1 |
Y |
| NEPHELOMETRIC, AMYLASE |
Clinical Chemistry |
KHM |
862.1070 |
2 |
N |
| NERVE,STIMULATOR,ELECTRICAL,PERCUTANEOUS (PENS) FOR PAIN RELIEF |
Neurology |
NHI |
882.5890 |
2 |
N |
| NEURAMININASE (SIALIDASE) |
Pathology |
IBE |
864.4400 |
1 |
Y |
| NEUTRAL RED |
Pathology |
KFE |
864.1850 |
1 |
Y |
| NG1M(A), ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DGX |
866.5065 |
1 |
Y |
| NG3M(BO), ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DHI |
866.5065 |
1 |
Y |
| NG3M(G), ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DHQ |
866.5065 |
1 |
Y |
| NG4M(A), ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DHY |
866.5065 |
1 |
Y |
| NIGROSIN |
Pathology |
KKD |
864.1850 |
1 |
Y |
| NILE BLUE |
Pathology |
HZE |
864.1850 |
1 |
Y |
| NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE |
Clinical Chemistry |
JNB |
862.1555 |
2 |
N |
| NINHYDRIN, NITROGEN (AMINO-NITROGEN) |
Clinical Chemistry |
JMX |
862.1515 |
1 |
Y |
| NIPPER, MALLEUS |
Ear, Nose, Throat |
JYR |
874.4420 |
1 |
Y |
| NIPPLE, LAMBS FEEDING |
General Hospital |
FNN |
880.5640 |
1 |
Y |
| NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES |
Clinical Chemistry |
CJE |
862.1050 |
2 |
N |
| NITROPRUSSIDE REACTION (QUALITATIVE, URINE), CYSTINE |
Clinical Chemistry |
JLC |
862.1240 |
1 |
Y |
| NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) |
Clinical Chemistry |
JIN |
862.1435 |
1 |
Y |
| NITROSALICYLATE REDUCTION, AMYLASE |
Clinical Chemistry |
CJD |
862.1070 |
2 |
N |
| NONABSORBABLE GAUZE,SURGICAL SPONGE,& WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) |
General Hospital |
MXI |
|
|
N |
| NUCLEAR FAST RED |
Pathology |
HZF |
864.1850 |
1 |
Y |
| NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN TEST |
Microbiology |
NJR |
866.3740 |
1 |
N |
| NYSTAGMOGRAPH |
Neurology |
GWN |
882.1460 |
2 |
N |
