VITEK GRAM-NEGATIVE IDENTIFICATION CARD— 510(k) K883558

Name: FDA 510(k) clearance K883558
Creator: U.S. Food and Drug Administration
Published: 1988-09-16

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K883558 for VITEK GRAM-NEGATIVE IDENTIFICATION CARD, Substantially Equivalent on 1988-09-16. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-08-19
Decision date: 1988-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

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