FDA 510(k) Application Details - K200065

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K200065
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	Kaitlyn Hameister Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2020
Decision Date	02/10/2020
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