FDA 510(k) Application Details - K032897

Device Classification Name	Reagents, Clostridium Difficile Toxin   More FDA Info for this Device
510(K) Number	K032897
Device Name	Reagents, Clostridium Difficile Toxin
Applicant	IVD RESEARCH, INC. 5909 SEA LION PLACE, SUITE D CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	DAVE LAMBILLOTTE Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2003
Decision Date	05/27/2004
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