FDA 510(k) Application Details - K172255

Device Classification Name	Panels, Test, Susceptibility, Antimicrobial   More FDA Info for this Device
510(K) Number	K172255
Device Name	Panels, Test, Susceptibility, Antimicrobial
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	LTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2017
Decision Date	12/01/2017
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