GLYCA-DIRECT FRUCTOSAMINE— 510(k) K023654

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K023654 for GLYCA-DIRECT FRUCTOSAMINE, Substantially Equivalent on 2003-05-02. Applicant: Polymedco, Inc..

Clearance details

Applicant: Polymedco, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2002-10-30
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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