ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY— 510(k) K031857

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K031857 for ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY, Substantially Equivalent on 2003-09-04. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code DEM
Advisory panel: Immunology
Date received: 2003-06-16
Decision date: 2003-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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