AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K021151

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K021151 for AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-07-13. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code JIF
Advisory panel: Clinical Chemistry
Date received: 2002-04-10
Decision date: 2002-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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