HEMOLAB COFAC IX— 510(k) K942050

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K942050 for HEMOLAB COFAC IX, Substantially Equivalent on 1995-05-19. Applicant: Biomerieux Vitek, Inc.. Device class: 2.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1994-04-28
Decision date: 1995-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.