HEMOLAB SILIMAT REAGENT— 510(k) K920001

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K920001 for HEMOLAB SILIMAT REAGENT, Substantially Equivalent on 1992-09-25. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code GFI
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1992-01-02
Decision date: 1992-09-25
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.