POLYMEDCO OC LIGHT FOBT TEST— 510(k) K041297

Substantially Equivalent

Polymedco, Inc.

FDA 510(k) clearance K041297 for POLYMEDCO OC LIGHT FOBT TEST, Substantially Equivalent on 2004-08-12. Applicant: Polymedco, Inc..

Clearance details

Applicant: Polymedco, Inc.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2004-05-14
Decision date: 2004-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

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