CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM— 510(k) K012357

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K012357 for CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM, Substantially Equivalent on 2002-02-28. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2001-07-25
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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