FDA 510(k) Application Details - K061101

Device Classification Name	Antisera, Cf, Influenza Virus A, B, C   More FDA Info for this Device
510(K) Number	K061101
Device Name	Antisera, Cf, Influenza Virus A, B, C
Applicant	DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	GAIL R GOODRUM Other 510(k) Applications for this Contact
Regulation Number	866.3330   More FDA Info for this Regulation Number
Classification Product Code	GNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2006
Decision Date	11/20/2006
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