VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY— 510(k) K080931

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K080931 for VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY, Substantially Equivalent on 2008-06-11. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LLH
Advisory panel: Microbiology
Date received: 2008-04-02
Decision date: 2008-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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