FDA 510(k) Application Details - K163184

Device Classification Name	Dna-Reagents, Neisseria   More FDA Info for this Device
510(K) Number	K163184
Device Name	Dna-Reagents, Neisseria
Applicant	Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	David W. Gates Other 510(k) Applications for this Contact
Regulation Number	866.3390   More FDA Info for this Regulation Number
Classification Product Code	LSL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2016
Decision Date	02/09/2017
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