VIDAS C DIFFICILE GDH

Antigen, C. Difficile

BIOMERIEUX SA

The following data is part of a premarket notification filed by Biomerieux Sa with the FDA for Vidas C Difficile Gdh.

Pre-market Notification Details

Device IDK132010
510k NumberK132010
Device Name:VIDAS C DIFFICILE GDH
ClassificationAntigen, C. Difficile
Applicant BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne,  FR 69290
ContactCaroline Koch-mathian
CorrespondentCaroline Koch-mathian
BIOMERIEUX SA 5 RUE DES AQUEDUCS Craponne,  FR 69290
Product CodeMCB  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-01
Decision Date2013-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026444204 K132010 000

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