CRITSPIN MANUFACTURED BY IRIS SAMPLE PROCESSING

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CRITSPIN

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	GKG
FDA Classification Name	CENTRIFUGE, HEMATOCRIT
FDA Device Classification Code	Standards
FDA Regulation Number	864.6400
FDA Common Generic Name	CENTRIFUGE AND ACCESSORIES
FDA Proprietary Device Name	CRITSPIN
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 RR - Repackager/Relabeller
FDA Listing Date	11-02-98
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	ANDREAS HETTICH GMBH GMBH & CO. KG FOEHRENSTRASSE 12 TUTTLINGEN, D-78532 GM 49-746-17050 / 978-232-3957	HAEMTOKRIT 210	CENTRIFUGE FOR DETERMINING HEMATOCRIT
2	BECTON, DICKINSON & CO. 7 LOVETON CIR. SPARKS, MD 21152 US 201-847-6800 / 410-316-4000 4099	MULTIPLE MICRO-HEMATOCRIT CENTRIFUGE	VARIOUS MICRO-HEMATOCRIT CENTRIFUGE
3	BIO PLAS, INC. 820 EUBANKS DR., #I VACAVILLE, CA 95688 US 415-472-3777 / 415-472-3777	BIO PLAS , INC.	MICROCENTRIFIGE TUBES
4	DIGISYSTEM LABORATORY INSTRUMENTS INC. NO. 9, LANE 269, FU DE I RD. HSI CHIH CITY,TAIPEI, TW 886-2-26941738 / 770-270-1394 4345	M24, M240C	VARIOUS TYPES OF HEMATOCRIT CENTRIFUGES
5	ELECTRA MEDICAL CORP. 17 TOWN FOREST RD. OXFORD, MA 01540 US 508-987-0491 / 508-987-0491	MULTIPLE	HEMATOCRIT CENTRIFUGE
6	GEMMY INDUSTRIAL CORP. 7F.#106, MIN CHUAN WEST RD. TAIPEI, 103 TW 886-2-25531456 / 886-3-5208829	MULTIPLE	VARIOUS
7	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	IRMA SL ANALYZER	BLOOD ANALYZER
8	INTERNATIONAL TECHNIDYNE INCORPORATED 2656 PATTON RD. ROSEVILLE, MN 55113 US 732-548-5700 / 732-548-5700 265	IRMA SL	BLOOD ANALYZER
9	NUVE SANAYI MALZEMELERI IMALAT VE TICAROT A.S. ESENBOGA YOLU, 22 KM AKYURT, ANKARA, 06287 TU	CENTRIFUGE, HEMATOCRIT (MULTIPLE BRANDS)	HEMATOCRIT CENTRIFUGE
10	PRESVAC SRL CALLE 34 (EX. FRANCIA) 3917 SAN MARTIN BUENOS AIRES PROV., B1650IHM AR 541-147-543532 / 908-362-6807	PRESVAC SRL	VARIOUS TYPES OF CENTRIFUGES CMH-28
11	SEPARATION TECHNOLOGY, INC. 1096 RAINER DR. ALTAMONTE SPRINGS, FL 32714 US 412-490-8425 / 412-490-8425	MULTIPLE	VARIOUS HEMATOCRIT CENTRIFUGES
12	SHANGHAI LW SCIENTIFIC CO., LTD. NO.4433 CHUAN ZHOU RD. NANHUI, SHANGHAI, CH 86-21-5811-3148 / 770-270-1394 4345	ZIPOCRIT	PORTABLE HEMATOCRIT CENTRIFUGE