FDA 510(k) Application Details - K132010

Device Classification Name	Antigen, C. Difficile   More FDA Info for this Device
510(K) Number	K132010
Device Name	Antigen, C. Difficile
Applicant	BIOMERIEUX SA 5 RUE DES AQUEDUCS CRAPONNE 69290 FR Other 510(k) Applications for this Company
Contact	CAROLINE KOCH-MATHIAN Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	MCB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2013
Decision Date	10/09/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review