IQ200 URINE ANALYZER BODY FLUIDS MODULE MANUFACTURED BY IRIS DIAGNOSTICS

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IQ200 URINE ANALYZER BODY FLUIDS MODULE

Request for Information Form	Contact Information
Company Name	IRIS DIAGNOSTICS
Address	9172 ETON AVE.
City, State, Zip	CHATSWORTH, CA 91311
Country	US
FDA Owner/Operator Phone	818-709-1244 7129
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GKL
FDA Classification Name	COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
FDA Device Classification Code	Standards
FDA Regulation Number	864.5200
FDA Common Generic Name	BODY FLUIDS ANALYZER
FDA Proprietary Device Name	IQ200 URINE ANALYZER BODY FLUIDS MODULE
FDA Owner / Operator Number	2023446
FDA Owner / Operator Name	IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
FDA Establishment Registration Number	2023446
FDA Registered Establishment Name	IRIS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	10-09-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of IRIS DIAGNOSTICS

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT LABORATORIES 5440 PATRICK HENRY DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	MULTIPLE	HEMATOLOGY ANALYZER
2	APPLIED IMAGING CORP. 120 BAYTECH DR. SAN JOSE, CA 95134 US 408-719-6428 / 408-719-6428	MULTIPLE	CYTOVISION KARYOTYPER,GENEVISION KARYOTYPER
3	BD BIOSCIENCES 2350 QUME DR. SAN JOSE, CA 95131 US 201-847-6800 / 408-954-6307	FACSORT FLOW CYTOMETER	FLOW CYTOMETER
4	BECKMAN COULTER, INC. 11800 SW 147TH AVE. MIAMI, FL 33196 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	AUTOMATED CELL COUNTER
5	BECKMAN COULTER, INC. 740 WEST 83RD ST. HIALEAH, FL 33014 US 714-871-4848 / 714-993-5321 8383	COULTER R PLATELET KIT	PLATELET KIT INTENDED FOR THE QUANTITATIVE ENUMERATION OF PLATELETS ON THE COULT
6	BECTON DICKINSON CARIBE LTD. VICKS DR., LOT #6 CAYEY, PR 00634 US 201-847-6800 / 410-316-4000 4099	VARIOUS MODELS OF QBC CENTRIFUGE HEMATOLOGY ANALYZER SYSTEMS	CENTRIFUGAL HEMATOLOGY ANALYZER
7	CELL SCIENCE SYSTEMS, LTD. CORP. 1239 E. NEWPORT CENTER DR. SUITE 101 DEERFIELD BEACH, FL 33442 US 954-426-2304 / 954-426-2304	ROBOCAT II	HEMATOLOGY PARTICLE COUNTER
8	DIAGNOSTIC TECHNOLOGY, INC. 175 COMMERCE DR. UNIT L HAUPPAUGE, NY 11788 US 631-582-4949 / 631-582-4949	PHA TM-1 PROGRAMMABLE HEMATOLOGY ANALYZER	CBC HEMATOLOGY ANALYZER
9	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	ADVIA 120 HEMATOLOGY SYSTEM, INVITRO DIAGNOSTIC SYSTEM	AUTOMATED COMPLETE BLOOD CELL & DIFFERENTIAL CELL COUNTER
10	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	DANAM ELEC ST-1000 MULTIPLE DIAGNOSIS PRODUCTS	DANAM ELEC ST-1000 MULTIPLE DIAGNOSIS PRODUCTS
11	HAMILTON THORNE BIOSCIENCES 181 ELLIOTT ST. 100 CUMMINGS CENTER-SUITE 465E BEVERLY, MA 01915 US 978-921-2050 / 978-921-2050	IVOS	SPERM CELL ANALYZER
12	HORIBA ABX, INC. 34 BUNSEN DR. IRVINE, CA 92618 US 33-467-141516 / 949-453-0500 208	MULTIPLE	AUTOMATED CELL COUNTER
13	LABCON, NORTH AMERICA 3700 LAKEVILLE HWY., STE. 200 PETALUMA, CA 94954 US 409-842-3714 / 707-766-2106	BLOOD CELL COUNTER VIALS	BLOOD CELL COUNTER VIALS
14	OPTIMA, INC. ROGIE BLDG. 5F, 1-48-11 ITABASHI, ITABASHI-KU TOKYO, 173-0004 JA 81-353-752351 / 847-758-8834	OPTIMA	OPTIMA
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA 120 HEMATOLOGY SYSTEM, INVITRO DIAGNOSTIC SYSTEM	AUTOMATED COMPLETE BLOOD CELL & DIFFERENTIAL CELL COUNTER
16	SYSMEX CORPORATION 4-4-4 TAKATSUKADAI NISHI-KU KOBE, 651-2271 JA 817-826-50500 / 847-996-4512	MULTIPLE	AUTOMATED CELL COUNTER
17	TECHNOMART, INC. ACE-TECHNO TOWER II-307,#197-7 KURO-DONG, KURO-GU SEOUL, 152-848 KS 822-862-3434 / 847-758-8834	OPTIMA	OPTIMA