FDA 510(k) Application Details - K081920

Device Classification Name	Reagents, Clostridium Difficile Toxin   More FDA Info for this Device
510(K) Number	K081920
Device Name	Reagents, Clostridium Difficile Toxin
Applicant	BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) 6146 NANCY RIDGE DR. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RAYMOND BOULE 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	07/03/2008
Decision Date	12/19/2008
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