FDA 510(k) Application Details - DEN200015

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200015
Device Name	cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Rita Hoady 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	03/02/2020
Decision Date	07/30/2020
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review