BIOMERIEUX HEMOLAB COFAC X— 510(k) K935851

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K935851 for BIOMERIEUX HEMOLAB COFAC X, Substantially Equivalent on 1995-01-17. Applicant: Biomerieux Vitek, Inc..

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GJT
Advisory panel: Hematology
Date received: 1993-12-08
Decision date: 1995-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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