VITEK RAPID CALL-GRAM NEGATIV IDENT CARD— 510(k) K925915

Name: FDA 510(k) clearance K925915
Creator: U.S. Food and Drug Administration
Published: 1993-03-23

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K925915 for VITEK RAPID CALL-GRAM NEGATIV IDENT CARD, Substantially Equivalent on 1993-03-23. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LQM
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1992-11-23
Decision date: 1993-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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