FDA 510(k) Application Details - K043341

Device Classification Name	Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease   More FDA Info for this Device
510(K) Number	K043341
Device Name	Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Applicant	BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER BENTSEN Other 510(k) Applications for this Contact
Regulation Number	862.3100   More FDA Info for this Regulation Number
Classification Product Code	NVI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2004
Decision Date	10/27/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review