K053090

Substantially Equivalent

DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR

Applicant: Beckman Coulter, Inc.
Product code: JFM
Advisory panel: Clinical Chemistry
Date received: 2005-11-02
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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