POLY-CHEM 90 TOTAL BILIRUBIN— 510(k) K111143

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K111143 for POLY-CHEM 90 TOTAL BILIRUBIN, Substantially Equivalent on 2011-09-01. Applicant: Polymedco, Inc..

Clearance details

Applicant: Polymedco, Inc.
Product code: 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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