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510(k) Premarket Notification Database

Device Classification Name:	ENZYME IMMUNOASSAY, BENZODIAZEPINE
Regulation Number:	862.3170 [See Other Products with this regulation number]
510(k) Number:	K032365
Device Name:	BENZODIAZEPINE ENZYME IMMUNOASSAY
Applicant:	LIN-ZHI INTERNATIONAL, INC. 687 NORTH PASTORIA AVE. SUNNYVALE, CA 94085 2917
Contact:	CHENG-I LIN
Product Code:	JXM [See Other Manufacturers that make this Product]
Date Received:	07-31-2003
Decision Date:	09-05-2003
Decision:	CS
Advisory Committee:	TX
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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