PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM— 510(k) K022177

Substantially Equivalent

Bayer Diagnostics Corp.

FDA 510(k) clearance K022177 for PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM, Substantially Equivalent on 2002-12-17. Applicant: Bayer Diagnostics Corp..

Clearance details

Applicant: Bayer Diagnostics Corp.
Product code: Code LTJ
Advisory panel: Immunology
Date received: 2002-07-03
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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