FDA 510(k) Application Details - K093604

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K093604
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	AB BIOMERIEUX DALVAGEN 10 SOLNA 16956 SE 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	11/20/2009
Decision Date	08/25/2010
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