RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA— 510(k) K910304

Name: FDA 510(k) clearance K910304
Creator: U.S. Food and Drug Administration
Published: 1991-07-26

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K910304 for RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA, Substantially Equivalent on 1991-07-26. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LQL
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1991-01-24
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

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