I-STAT CK-MB TEST MANUFACTURED BY ABBOTT POINT OF CARE INC.

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Request for Information Form	Contact Information
Company Name	ABBOTT POINT OF CARE INC.
Address	104 WINDSOR CENTER DR.
City, State, Zip	EAST WINDSOR, NJ 08520
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	MYT
FDA Classification Name	BIOSENSOR, IMMUNOASSAY, CPK OR ISOENZYMES
FDA Device Classification Code	Standards
FDA Regulation Number	862.1215
FDA Common Generic Name	CREATINE KINASE MB
FDA Proprietary Device Name	I-STAT CK-MB TEST
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2245578
FDA Registered Establishment Name	ABBOTT POINT OF CARE INC.
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	02-22-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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 CK-MB TEST	CREATINE KINASE MB
2	ABBOTT POINT OF CARE CANADA LIMITED 436 HAZELDEAN ROAD KANATA, ONTARIO, K2L 1T9 CA 847-937-6100 / 847-938-3471	I-STAT CK-MB TEST	CREATINE KINASE MB