FDA 510(k) Application Details - DEN160032

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160032
Device Name	Accelerate Pheno system, Accelerate Phenotest BC Kit
Applicant	ACCELERATE DIAGNOTICS 3950 S. COUNTRY CLUB ROAD #470 TUCSON, AZ 85714 US Other 510(k) Applications for this Company
Contact	MAUREEN MENDE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2016
Decision Date	02/23/2017
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review