FDA 510(k) Application Details - K140851

Device Classification Name	Influenza A Virus Subtype Differentiation Nucleic Acid Assay   More FDA Info for this Device
510(K) Number	K140851
Device Name	Influenza A Virus Subtype Differentiation Nucleic Acid Assay
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON ROAD, MAILSTOP D-30 ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	CDR YON YU, PHARM.D. Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2014
Decision Date	04/25/2014
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