FDA Product Classification Codes Begining with "K"
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D
E
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X
Y
Z
| FDA Device Classification |
Medical Specialty |
FDA Product Code |
FDA Regulation Number |
Device Class |
510k Exempt? |
| KAPPA, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DFH |
866.5550 |
2 |
N |
| KAPPA, FITC, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DEO |
866.5550 |
2 |
N |
| KAPPA, PEROXIDASE, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DFD |
866.5550 |
2 |
N |
| KAPPA, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL |
Immunology |
DEK |
866.5550 |
2 |
N |
| KERATINS, HISTOLOGICAL |
Pathology |
LSP |
|
|
N |
| KERATOME, AC-POWERED |
Opthalmic |
HNO |
886.4370 |
1 |
N |
| KERATOME, BATTERY-POWERED |
Opthalmic |
HMY |
886.4370 |
1 |
N |
| KERATOME,WATER JET |
Opthalmic |
MYD |
886.4370 |
1 |
N |
| KERATOPROSTHESIS, PERMANENT IMPLANT |
Opthalmic |
HQM |
886.3400 |
2 |
N |
| KERATOPROSTHESIS, TEMPORARY IMPLANT, SURGICAL USE |
Opthalmic |
MLP |
886.3400 |
2 |
N |
| KERATOSCOPE, AC-POWERED |
Opthalmic |
HLQ |
886.1350 |
1 |
Y |
| KERATOSCOPE, BATTERY-POWERED |
Opthalmic |
HLR |
886.1350 |
1 |
Y |
| KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE |
Clinical Chemistry |
JQB |
862.1360 |
1 |
Y |
| KIT, ANAEROBIC IDENTIFICATION |
Microbiology |
JSP |
866.2660 |
1 |
Y |
| KIT, ASSAY, ESTROGEN RECEPTOR |
Clinical Chemistry |
LPJ |
864.1860 |
3 |
N |
| KIT, ASSAY, PROGESTERONE RECEPTOR |
Clinical Chemistry |
LPI |
864.1860 |
3 |
N |
| KIT, BALLOON REPAIR, CATHETER |
Cardiovascular |
DQP |
870.1350 |
3 |
N |
| KIT, BARIUM ENEMA, DISPOSABLE |
Radiology |
FCD |
|
|
N |
| KIT, BONE MARROW COLLECTION/TRANSFUSION |
General Hospital |
LWE |
|
|
N |
| KIT, CELL HARVASTING, ENDOTHELIAL |
Cardiovascular |
MFY |
|
3 |
N |
| KIT, CELL SCREENING, FETAL |
Hematology |
MTI |
|
|
N |
| KIT, CERVICAL, SMEAR |
Obstetrics/Gynecology |
MCO |
|
3 |
N |
| KIT, CHEMICAL SNAKE-BITE |
General Hospital |
KYQ |
880.5760 |
3 |
N |
| KIT, CONDUCTION ANESTHETIC |
Anesthesiology |
CAZ |
868.5140 |
2 |
N |
| KIT, CULTURE, CHROMOSOME |
Pathology |
KIQ |
864.2260 |
1 |
Y |
| KIT, DECONTAMINATION |
General Plastic Surgery |
MAC |
|
|
N |
| KIT, DENTURE REPAIR, OVER THE COUNTER |
Dental |
EBO |
872.3570 |
2 |
N |
| KIT, DIRECT ANTIGEN, NEGATIVE CONTROL |
Microbiology |
MKA |
862.1660 |
1 |
N |
| KIT, DIRECT ANTIGEN, POSITIVE CONTROL |
Microbiology |
MJZ |
862.1660 |
1 |
N |
| KIT, DISC, AGAR GEL DIFFUSION, DETERMINE SERUM LEVELS OF GENTAMICIN |
Clinical Toxicology |
KZT |
862.3450 |
2 |
N |
| KIT, DISC, AGAR GEL DIFFUSION, DETERMINE SERUM LEVELS OF KANAMYCIN |
Clinical Toxicology |
KZW |
862.3520 |
2 |
N |
| KIT, DISC, AGAR GEL DIFFUSION, DETERMINE SERUM LEVELS OF TOBRAMYCIN |
Clinical Toxicology |
KZX |
862.3900 |
2 |
N |
| KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Microbiology |
MAQ |
|
3 |
N |
| KIT, EARMOLD, IMPRESSION |
Ear, Nose, Throat |
LDG |
|
|
N |
| KIT, ENEMA, (FOR CLEANING PURPOSE) |
Gastroenterology/Urology |
FCE |
876.5210 |
1 |
Y |
| KIT, FASTIDIOUS ORGANISMS |
Microbiology |
JST |
866.2660 |
1 |
Y |
| KIT, FIRST AID |
General Plastic Surgery |
LRR |
|
|
N |
| KIT, I.V. START |
General Plastic Surgery |
LRS |
|
|
N |
| KIT, IDENTIFICATION, DERMATOPHYTE |
Microbiology |
JSR |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, ENTEROBACTERIACEAE |
Microbiology |
JSS |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, GLUCOSE NONFERMENTER |
Microbiology |
JSW |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, MYCOBACTERIA |
Microbiology |
JSY |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, NEISSERIA GONORRHOEAE |
Microbiology |
JSX |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, PSEUDOMONAS |
Microbiology |
JSZ |
866.2660 |
1 |
Y |
| KIT, IDENTIFICATION, YEAST |
Microbiology |
JXB |
866.2660 |
1 |
Y |
| KIT, IGG, PLATELET ASSOCIATED |
Hematology |
LLG |
|
|
N |
| KIT, LABOR AND DELIVERY |
Obstetrics/Gynecology |
MLS |
|
|
N |
| KIT, MYCOPLASMA DETECTION |
Pathology |
KIW |
864.2360 |
1 |
Y |
| KIT, PELVIC EXAM |
Obstetrics/Gynecology |
MLT |
|
|
N |
| KIT, PLASTIC SURGERY AND ACCESSORIES |
General Plastic Surgery |
FTN |
878.3925 |
1 |
Y |
| KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS |
Hematology |
KSF |
864.9650 |
2 |
N |
| KIT, QUALITY CONTROL FOR CULTURE MEDIA |
Microbiology |
JTR |
866.2480 |
1 |
Y |
| KIT, REPAIR, CATHETER, HEMODIALYSIS |
Gastroenterology/Urology |
NFK |
876.5540 |
2 |
N |
| KIT, SAMPLE COLLECTION, HIV |
Hematology |
MTK |
|
3 |
N |
| KIT, SAMPLING, ARTERIAL BLOOD |
Anesthesiology |
CBT |
868.1100 |
1 |
Y |
| KIT, SCREENING, STAPHYLOCOCCUS AUREUS |
Microbiology |
JWX |
866.2660 |
1 |
Y |
| KIT, SCREENING, TRICHOMONAS |
Microbiology |
JWZ |
866.2660 |
1 |
Y |
| KIT, SCREENING, URINE |
Microbiology |
JXA |
866.2660 |
1 |
Y |
| KIT, SCREENING, YEAST |
Microbiology |
JXC |
866.2660 |
1 |
Y |
| KIT, SEROLOGICAL, NEGATIVE CONTROL |
Microbiology |
MJY |
862.1660 |
1 |
N |
| KIT, SEROLOGICAL, POSITIVE CONTROL |
Microbiology |
MJX |
862.1660 |
1 |
N |
| KIT, SUCTION, SNAKE-BITE |
General Hospital |
KYP |
880.5740 |
1 |
Y |
| KIT, SURGICAL - GENERAL |
General Plastic Surgery |
LRO |
|
|
N |
| KIT, SURGICAL INSTRUMENT, DISPOSABLE |
General Plastic Surgery |
KDD |
878.4800 |
1 |
Y |
| KIT, SUTURE REMOVAL |
General Plastic Surgery |
MCZ |
|
|
N |
| KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS |
Immunology |
LOK |
|
3 |
N |
| KIT, TEST, COAGGLUTININ |
Hematology |
MHS |
|
3 |
N |
| KIT, TEST, IN VITRO PERIODONTAL |
Dental |
MCL |
|
3 |
N |
| KIT, TEST, MALARIA |
Clinical Toxicology |
NED |
|
|
N |
| KIT, TEST, MULTIPLE, DRUGS OF ABUSE, OVER THE COUNTER |
Clinical Toxicology |
MVO |
|
2 |
N |
| KIT, TEST, PERIODONTAL |
Dental |
LXX |
|
3 |
N |
| KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER |
Clinical Chemistry |
LCX |
862.1155 |
2 |
N |
| KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER |
Immunology |
LOJ |
866.6010 |
2 |
N |
| KIT, TRACHEOSTOMY AND NASAL SUCTIONING |
General Plastic Surgery |
LRQ |
|
|
N |
| KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER |
Gastroenterology/Urology |
FCN |
876.5250 |
2 |
Y |
| KIT, WOUND DRESSING |
General Plastic Surgery |
MCY |
|
|
N |
| KIT,ANTIBODY,ELUTION |
Hematology |
MYQ |
|
2 |
N |
| KIT,CORD BLOOD COLLECTION |
Hematology |
MYK |
|
2 |
N |
| KIT,TEST(DONORS),FOR BLOODBORNE PATHOGEN |
Immunology |
MYZ |
|
2 |
N |
| KIT,TEST,QUALITY CONTROL FOR ENDOTOXIN |
Immunology |
MZL |
|
|
N |
| KIT,TEST,SALIVA,HIV-1&2 |
Hematology |
MWB |
|
|
N |
| KIT,TYPING,HLA-DQB |
Hematology |
MVS |
|
|
N |
| KIT,WESTERN BLOT,HIV-1 |
Hematology |
MVW |
|
|
N |
| KNIFE, AMPUTATION |
General Plastic Surgery |
GDN |
878.4800 |
1 |
Y |
| KNIFE, CERVICAL CONE |
Obstetrics/Gynecology |
HDZ |
884.4530 |
2 |
N |
| KNIFE, EAR |
Ear, Nose, Throat |
JYO |
874.4420 |
1 |
Y |
| KNIFE, ENT |
Ear, Nose, Throat |
KTG |
874.4420 |
1 |
Y |
| KNIFE, LARYNGEAL |
Ear, Nose, Throat |
JZY |
874.4420 |
1 |
Y |
| KNIFE, MARGIN FINISHING, OPERATIVE |
Dental |
EJZ |
872.4565 |
1 |
Y |
| KNIFE, MYRINGOTOMY |
Ear, Nose, Throat |
JYP |
874.4420 |
1 |
Y |
| KNIFE, NASAL |
Ear, Nose, Throat |
KAS |
874.4420 |
1 |
Y |
| KNIFE, OPHTHALMIC |
Opthalmic |
HNN |
886.4350 |
1 |
Y |
| KNIFE, OPHTHALMIC, REPROCESSED |
Opthalmic |
NLA |
886.4350 |
1 |
N |
| KNIFE, ORTHOPEDIC |
Orthopedic |
HTS |
888.4540 |
1 |
Y |
| KNIFE, PERIODONTIC |
Dental |
EMO |
872.4565 |
1 |
Y |
| KNIFE, SURGICAL |
General Plastic Surgery |
EMF |
878.4800 |
1 |
Y |
| KNIFE, TONSIL |
Ear, Nose, Throat |
KBQ |
874.4420 |
1 |
Y |
|
