FDA 510(k) Application Details - K971101

Device Classification Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2   More FDA Info for this Device
510(K) Number	K971101
Device Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Applicant	VIRAL ANTIGENS, INC. 5171 WILFONG RD. MEMPHIS, TN 38134 US Other 510(k) Applications for this Company
Contact	TERRY S RATCLIFFE 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	03/26/1997
Decision Date	07/01/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review