FDA 510(k) Application Details - K102535

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K102535
Device Name	Manual Antimicrobial Susceptibility Test Systems
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	866.1640   More FDA Info for this Regulation Number
Classification Product Code	JWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2010
Decision Date	05/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review