VIDAS ROTAVIRUS ASSAY— 510(k) K965092

Substantially Equivalent

Biomerieux Vitek, Inc.

FDA 510(k) clearance K965092 for VIDAS ROTAVIRUS ASSAY, Substantially Equivalent on 1997-05-05. Applicant: Biomerieux Vitek, Inc..

Clearance details

Applicant: Biomerieux Vitek, Inc.
Product code: Code LIQ
Advisory panel: Microbiology
Date received: 1996-12-19
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, US

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