FDA 510(k) Application Details - K152346

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K152346
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	BECKMAN COULTER, INC. 1584 ENTERPRISE BLVD. WEST SACRAMENTO, CA 95691 US Other 510(k) Applications for this Company
Contact	SHANNON POPSON 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	08/20/2015
Decision Date	09/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review