VIDAS C DIFFICILE GDH— 510(k) K132010

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K132010 for VIDAS C DIFFICILE GDH, Substantially Equivalent on 2013-10-09. Applicant: Biomerieux S.A.. Device class: 1.

Clearance details

Applicant: Biomerieux S.A.
Product code: Code MCB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 2013-07-01
Decision date: 2013-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Craponne, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.