TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY— 510(k) K972640

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K972640 for TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY, Substantially Equivalent on 1998-01-09. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code DEM
Advisory panel: Immunology
Date received: 1997-07-15
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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