CRITSPIN DIGITAL HEMATOCRIT READER MANUFACTURED BY IRIS SAMPLE PROCESSING

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CRITSPIN DIGITAL HEMATOCRIT READER

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	HE - Hematology
FDA Product Code	JPI
FDA Classification Name	DEVICE, HEMATOCRIT MEASURING
FDA Device Classification Code	Standards
FDA Regulation Number	864.6400
FDA Common Generic Name	HEMATOCRIT MEASURING DEVICE AND ACCESSORIES
FDA Proprietary Device Name	CRITSPIN DIGITAL HEMATOCRIT READER
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	10-23-00
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	ABBOTT POINT OF CARE CANADA LIMITED 185 CORKSTOWN ROAD NEPEAN, ONTARIO, K2H 8V4 CA 847-937-6100 / 847-938-3471	I-STAT PORTABLE CLINICAL ANALYZER & CARTRIDGES	HEMATOCRIT TEST
2	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	I-STAT PORTABLE CLINICAL ANALYZER AND CARTRIDGES	I-STAT SYSTEM
3	ABBOTT POINT OF CARE INC. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US 847-937-6100 / 847-938-3471	I-STAT PORTABLE CLINICAL ANALYZER AND CARTRIDGES	I-STAT SYSTEM
4	BAXTER HEALTHCARE CORP., RENAL DIVISION 7511 114TH AVENUE NORTH LARGO, FL 33773 US 847-948-2000 / 847-473-6141	DEVICE, HEMATOCRIT MEASURING	DEVICE, HEMATOCRIT MEASURING
5	BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099	MICRO-HEMATOCRIT READER	MICRO-HEMATOCRIT READER
6	EPOCAL, INC. 2935 CONROY ROAD OTTAWA, ONTARIO, K1G-6C6 CA 613-738-6192 / 613-738-6192x258	EPOC BLOOD ANALYSIS SYSTEM	PORTABLE BLOOD ANALYZER
7	HEMA METRICS, INC. 695 NORTH, 900 WEST KAYSVILLE, UT 84037 US 801-451-9000 / 801-451-9000 165	CRIT-LINE	IN-LINE HEMATOCRIT/BLOOD VOLUME MONITOR
8	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454 US 781-894-0800 211 / 781-894-0800 211	MULTIPLE	VARIOUS
9	THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC 275 AIKEN ROAD ASHEVILLE, NC 28804 US / 828-658-4400	MULTIPLE	MICRO-CAPILLARY TUBE READER
10	VULCON TECHNOLOGIES 718 MAIN ST. GRANDVIEW, MO 64030 US 816-966-1212 / 816-966-1212	READER	POLYCARBONATE HEMATOCRIT READER