COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM— 510(k) K022288

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K022288 for COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM, Substantially Equivalent on 2002-12-17. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 2002-07-15
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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