FDA 510(k) Application Details - K080570

Device Classification Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna   More FDA Info for this Device
510(K) Number	K080570
Device Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD.,MS-C12 ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	STEPHEN LINDSTROM 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	02/29/2008
Decision Date	09/30/2008
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