CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K022178

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022178 for CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-11-12. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code MOI
Advisory panel: Immunology
Date received: 2002-07-03
Decision date: 2002-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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