FDA 510(k) Application Details - K203220

Device Classification Name	More FDA Info for this Device
510(K) Number	K203220
Device Name	cobas BKV
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Raji Grewal Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2020
Decision Date	01/29/2021
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