FDA 510(k) Application Details - K083278

Device Classification Name	Novel Influenza A Virus, A/H5 Ns1 Protein   More FDA Info for this Device
510(K) Number	K083278
Device Name	Novel Influenza A Virus, A/H5 Ns1 Protein
Applicant	ARBOR VITA CORPORTATION 772 LUCERNE DRIVE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	LINDA ALLISTER Other 510(k) Applications for this Contact
Regulation Number	866.3332   More FDA Info for this Regulation Number
Classification Product Code	OMS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2008
Decision Date	04/08/2009
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