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510(k) Premarket Notification Database

Device Classification Name:	ACTIVATED WHOLE BLOOD CLOTTING TIME
Regulation Number:	864.7140 [See Other Products with this regulation number]
510(k) Number:	K023582
Device Name:	I-STAT KAOLIN ACT TEST
Applicant:	I-STAT CORPORATION 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520
Contact:	PAUL VANDERWERF
Product Code:	JBP [See Other Manufacturers that make this Product]
Date Received:	10-24-2002
Decision Date:	09-08-2003
Decision:	SE
Advisory Committee:	HE
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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