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

Name: FDA 510(k) clearance K022288
Creator: U.S. Food and Drug Administration
Published: 2002-12-17

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.. Device class: 2.

Clearance details

Applicant: Bayer Corp.
Product code: Code LTJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2002-07-15
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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