FDA 510(k) Application Details - DEN190016

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190016
Device Name	cobas vivoDx MRSA
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Nobuko Nakajima Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2019
Decision Date	12/05/2019
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