FDA 510(k) Application Details - K971662

Device Classification Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2   More FDA Info for this Device
510(K) Number	K971662
Device Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Applicant	DIAGNOSTIC HYBRIDS, INC. ONE PRESIDENT ST. ATHENS, OH 45701 US Other 510(k) Applications for this Company
Contact	J.L. BROWN Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	GQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/1997
Decision Date	11/18/1997
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