K061139

Substantially Equivalent

BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

Applicant: Bayer Healthcare, LLC
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2006-04-24
Decision date: 2006-07-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tarrytown, NY, US

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