K-number	K972640
Device name	TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
Applicant	Boehringer Mannheim Corp.
Product code	DEM
Device class	Class II
Decision date	Jan 9, 1998
Decision	Substantially Equivalent
Regulation	866.5130

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View the full FDA submission: accessdata.fda.gov

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TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY

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