FDA 510(k) Application Details - DEN060008

Device Classification Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna   More FDA Info for this Device
510(K) Number	DEN060008
Device Name	Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD. NE (MS C-12) ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	HYE-JOO KIM 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	01/27/2006
Decision Date	02/03/2006
Decision	DENG -
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review