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510(k) Premarket Notification Database

Device Classification Name:	ANTIGEN, ANTISERUM, CONTROL, ALPHA-1-ANTITRYPSIN
Regulation Number:	866.5130 [See Other Products with this regulation number]
510(k) Number:	K031857
Device Name:	ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
Applicant:	BAYER DIAGNOSTICS CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591 5097
Contact:	ANDRES HOLLE
Product Code:	DEM [See Other Manufacturers that make this Product]
Date Received:	06-18-2003
Decision Date:	09-04-2003
Decision:	CS
Advisory Committee:	CH
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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