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

Name: FDA 510(k) clearance K012357
Creator: U.S. Food and Drug Administration
Published: 2002-02-28

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.. Device class: 2.

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2001-07-25
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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