K022288

Substantially Equivalent

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

Applicant: Bayer Corp.
Product 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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