VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)— 510(k) K891385

Name: FDA 510(k) clearance K891385
Creator: U.S. Food and Drug Administration
Published: 1989-04-18

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K891385 for VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS), Substantially Equivalent on 1989-04-18. Applicant: Vitek Systems, Inc.. Device class: 2.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1989-03-09
Decision date: 1989-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

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