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510(k) Premarket Notification Database

Device Classification Name:	KIT, PREGNANCY TEST, OVER THE COUNTER, HCG
Regulation Number:	862.1155 [See Other Products with this regulation number]
510(k) Number:	K032159
Device Name:	CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
Applicant:	ACCESS BIO INCORPORATE 675 US HIGHWAY 1 NORTH BRUNSWICK, NJ 08902
Contact:	YOUNG HO CHOI
Product Code:	LCX [See Other Manufacturers that make this Product]
Date Received:	07-15-2003
Decision Date:	09-05-2003
Decision:	CS
Advisory Committee:	CH
Statement/Summary/Purged Status:	Statement
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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