FDA 510(k) Application Details - K972975

Device Classification Name	Antiserum, Fluorescent, Rabies Virus   More FDA Info for this Device
510(K) Number	K972975
Device Name	Antiserum, Fluorescent, Rabies Virus
Applicant	LIGHT DIAGNOSTICS 28835 SINGLE OAK DR. TEMECULA, CA 92590 US Other 510(k) Applications for this Company
Contact	CINDY D PENNY Other 510(k) Applications for this Contact
Regulation Number	866.3460   More FDA Info for this Regulation Number
Classification Product Code	GOI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/1997
Decision Date	12/22/1998
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