FDA 510(k) Application Details - K121002

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K121002
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US Other 510(k) Applications for this Company
Contact	JENNIFER CHIA-HSUAN LIN 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	04/02/2012
Decision Date	10/12/2012
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