FDA 510(k) Application Details - K070206

Device Classification Name	Antigen, Cf, (Including Cf Control), Varicella-Zoster   More FDA Info for this Device
510(K) Number	K070206
Device Name	Antigen, Cf, (Including Cf Control), Varicella-Zoster
Applicant	DIAGNOSTIC HYBRIDS, INC. 350 WEST STATE ST. ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	GAIL GOODRUM Other 510(k) Applications for this Contact
Regulation Number	866.3900   More FDA Info for this Regulation Number
Classification Product Code	GQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2007
Decision Date	08/30/2007
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