GRAM NEGATIVE IDENTIFICATION PLUS CARD— 510(k) K962609

Name: FDA 510(k) clearance K962609
Creator: U.S. Food and Drug Administration
Published: 1996-08-30

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K962609 for GRAM NEGATIVE IDENTIFICATION PLUS CARD, Substantially Equivalent on 1996-08-30. Applicant: Biomerieux Vitek, Inc.. Device class: 1.

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LRH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-07-03
Decision date: 1996-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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