UROSTAT SG, BIOVATION MANUFACTURED BY IRIS SAMPLE PROCESSING

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UROSTAT SG, BIOVATION

Request for Information Form	Contact Information
Company Name	IRIS SAMPLE PROCESSING
Address	60 GLACIER DRIVE
City, State, Zip	WESTWOOD, MA 02090
Country	US
FDA Owner/Operator Phone	818-709-1244 7129
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	JRE
FDA Classification Name	REFRACTOMETER FOR CLINICAL USE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.2800
FDA Common Generic Name	REFRACTOMER AND ACCESSORIES
FDA Proprietary Device Name	UROSTAT SG, BIOVATION
FDA Owner / Operator Number	2023446
FDA Owner / Operator Name	IRIS INTERNATIONAL INC., A DIVISION OF IRIS IRIS I
FDA Establishment Registration Number	1221015
FDA Registered Establishment Name	IRIS SAMPLE PROCESSING
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	01-09-98
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of IRIS SAMPLE PROCESSING

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	AJINOMOTO TRADING, INC. EAST WING 7F, TFT BUILDING, 3-1-22 ARIAKE, KOTO-KU TOKYO, 135-8071 JA 81-335-284416 / 81-335-284416	BURTON AUTO REFKERATOMETER BARK-8	RC-380, BARK-8
2	ATAGO CO. 32-10 HONCHO ITABASHI-KU, TOKYO, JA 813-396-46131 / 425-637-2107	ATAGO	CLINICAL REFRACTOMETER
3	BHARAT ENTERPRISES D-1/3, SHIV PURI EXTN. DELHI, 110051 IN 91-225-17992 / 770-270-1394 4345	DIF50, DIF80	CELL COUNTER
4	COSMO CO.,LTD. 1-9-18,MINAMI-NAGASAKI,TOSHIMA KU TOKYO, 171 JA	CLINICAL REFRACTOMETER	CLINICAL REFRACTOMETER
5	DFI CO., LTD. 542-1 DAMAN-RI, JINRYE-MYUN GIMHAE-CITY, GYUNG-NAM, KS 82-55-3461882 / 909-980-9933	CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS	MULTIPLE REAGENT STRIPS
6	DIRUI INDUSTRIAL CO., LTD. 95 YUNHE ST., NEW & HIGH TECH DEVELOPMENT ZONE CHANGCHUN, 130012 CH 86-431-5100409 / 516-482-9001	DIRUI	MULTIPLE REAGENT STRIPS
7	ERMA INC. 2-31-6 YUSHIMA, BUNKYO-KU TOKYO, 113-0034 JA 81-33-8186281 / 81-33-8186281	SCHUCO CLINICAL REFRACTOMETER	CLINICAL REFRACTOMETER
8	MERCURY IRON & STEEL CO. 3401 VIRGINIA RD. CLEVELAND, OH 44122 US 216-831-1000 / 216-831-1000	MULTIPLE REFRACTOMETERS	REFRACTOMETERS FOR CLINICAL USES
9	OPTIMA, INC. ROGIE BLDG. 5F, 1-48-11 ITABASHI, ITABASHI-KU TOKYO, 173-0004 JA 81-353-752351 / 847-758-8834	OPTIMA	OPTIMA
10	REICHERT INC. 3362 WALDEN AVE. DEPEW, NY 14043 US 716-686-4500 / 716-686-4599	MULTIPLE	REFRACTOMETER FOR CLINICAL USE
11	SHANGHAI LW SCIENTIFIC CO., LTD. NO.4433 CHUAN ZHOU RD. NANHUI, SHANGHAI, CH 86-21-5811-3148 / 770-270-1394 4345	RFT10-2 HANDHELD REFRACTOMETER	REFRACTOMETER
12	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
13	TYLON INTERNATIONAL CO. FLAT, RM G 12/F, BLOCK 5 PIERHEAD GARDEN TUEN MUN, N.T., HK 852-240-4028 / 703-330-1413	PREMIERE	REFRACTOMETER
14	VEE GEE SCIENTIFIC, INC. 13600 N.E. 126TH PL., SUITE A KIRKLAND, WA 98034 US 206-823-4518 / 425-823-4518	VEE GEE CLINICAL REFRACTOMETER	CLINICAL REFRACTOMETER