FDA 510(k) Application Details - K081928

Device Classification Name	Respiratory Syncytial Virus, Antigen, Antibody, Ifa   More FDA Info for this Device
510(K) Number	K081928
Device Name	Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Applicant	DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	GAIL R GOODRUM Other 510(k) Applications for this Contact
Regulation Number	866.3480   More FDA Info for this Regulation Number
Classification Product Code	LKT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2008
Decision Date	12/23/2008
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