FDA 510(k) Application Details - K133869

Device Classification Name	More FDA Info for this Device
510(K) Number	K133869
Device Name	CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
Applicant	CENTER FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON ROAD, MS-C18 ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	HYE-JOO KIM Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2013
Decision Date	01/17/2014
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