CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM— 510(k) K022329

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022329 for CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2002-11-27. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LTK
Advisory panel: Immunology
Date received: 2002-07-18
Decision date: 2002-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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