FDA 510(k) Application Details - K240854

Device Classification Name	More FDA Info for this Device
510(K) Number	K240854
Device Name	Accelerate Arc System
Applicant	Accelerate Diagnostics Inc. 3950 South Country Club Road Tucson, AZ 85714 US Other 510(k) Applications for this Company
Contact	Jack Phillips Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2024
Decision Date	09/26/2024
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