FDA 510(k) Application Details - K192665

Device Classification Name	More FDA Info for this Device
510(K) Number	K192665
Device Name	Accelerate Pheno System, Accelerate PhenoTest BC Kit
Applicant	Accelerate Diagnostics, Inc. 3950 S. Country Club Road #470 Tucson, AZ 85714 US Other 510(k) Applications for this Company
Contact	Carrene Plummer 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	09/25/2019
Decision Date	09/15/2020
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