VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY— 510(k) K896097

Name: FDA 510(k) clearance K896097
Creator: U.S. Food and Drug Administration
Published: 1990-02-26

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K896097 for VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY, Substantially Equivalent on 1990-02-26. Applicant: Vitek Systems, Inc.. Device class: 1.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 1989-10-20
Decision date: 1990-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

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