FDA 510(k) Application Details - K991880

Device Classification Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2   More FDA Info for this Device
510(K) Number	K991880
Device Name	Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Applicant	LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. TEMECULA, CA 92590 US Other 510(k) Applications for this Company
Contact	CINDY PENNY 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	06/02/1999
Decision Date	11/09/1999
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