FDA 510(k) Application Details - K163085

Device Classification Name	More FDA Info for this Device
510(K) Number	K163085
Device Name	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
Applicant	Focus Diagnostics, Inc.: DBA DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 US Other 510(k) Applications for this Company
Contact	Irene M. Guzman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2016
Decision Date	02/14/2017
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