FDA 510(k) Application Details - K100287

Device Classification Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna   More FDA Info for this Device
510(K) Number	K100287
Device Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Applicant	U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND 1430 VETERANS DRIVE FORT DETRICK, MD US Other 510(k) Applications for this Company
Contact	ROBERT E MILLER Other 510(k) Applications for this Contact
Regulation Number	866.3332   More FDA Info for this Regulation Number
Classification Product Code	NXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/2010
Decision Date	07/06/2010
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