FDA 510(k) Application Details - K231306

Device Classification Name	More FDA Info for this Device
510(K) Number	K231306
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	Caroline Sobek 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	05/05/2023
Decision Date	06/01/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review