FDA 510(k) Application Details - K152523

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K152523
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY 1430 VETERANS DRIVE FORT DETRICK, MD 21702-9232 US Other 510(k) Applications for this Company
Contact	ROBERT E MILLER Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2015
Decision Date	10/01/2015
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