FDA 510(k) Application Details - K140426

Device Classification Name	More FDA Info for this Device
510(K) Number	K140426
Device Name	ANTHRACIS REAL-TIME PCR ASSAY
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 1600 CLIFTON RD. NE, 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	NHT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2014
Decision Date	05/22/2014
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