FDA 510(k) Application Details - K240867

Device Classification Name	More FDA Info for this Device
510(K) Number	K240867
Device Name	cobas« SARS-CoV-2 Qualitative for use on the cobas« 5800/6800/8800 Systems
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94028 US Other 510(k) Applications for this Company
Contact	Mounika Kommineni Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2024
Decision Date	02/11/2025
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