FDA 510(k) Application Details - K162385

Device Classification Name	More FDA Info for this Device
510(K) Number	K162385
Device Name	RAPIDEC CARBA NP
Applicant	BIOMERIEUX SA 5 RUE DES AQUEDUCS CRAPONNE 69290 FR Other 510(k) Applications for this Company
Contact	ASA KARLSSON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2016
Decision Date	04/27/2017
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