K111143

Substantially Equivalent

POLY-CHEM 90 TOTAL BILIRUBIN

Applicant: Polymedco, Inc.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 2011-04-22
Decision date: 2011-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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