FDA 510(k) Application Details - K223591

Device Classification Name	More FDA Info for this Device
510(K) Number	K223591
Device Name	cobas« SARS-CoV-2 & Influenza A/B for use on the cobas« Liat System
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Aradhana Karthikeyan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2022
Decision Date	07/27/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review