POLY-CHEM 90 ISE MODULE— 510(k) K112408

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K112408 for POLY-CHEM 90 ISE MODULE, Substantially Equivalent on 2011-11-04. Applicant: Polymedco, Inc..

Clearance details

Applicant: Polymedco, Inc.
Product code: Code CEM
Advisory panel: Clinical Chemistry
Date received: 2011-08-22
Decision date: 2011-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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