FDA 510(k) Application Details - K063675

Device Classification Name	Antiserum, Fluorescent, Chlamydia Trachomatis   More FDA Info for this Device
510(K) Number	K063675
Device Name	Antiserum, Fluorescent, Chlamydia Trachomatis
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	866.3120   More FDA Info for this Regulation Number
Classification Product Code	LJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2006
Decision Date	09/24/2007
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