FDA 510(k) Application Details - K243406

Device Classification Name	More FDA Info for this Device
510(K) Number	K243406
Device Name	cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Sumedha Sinha 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	11/01/2024
Decision Date	04/25/2025
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