AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K020807

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K020807 for AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-10-01. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LOJ
Advisory panel: Immunology
Date received: 2002-03-12
Decision date: 2002-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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