FDA 510(k) Application Details - K955067

Device Classification Name	Antigen, C. Difficile   More FDA Info for this Device
510(K) Number	K955067
Device Name	Antigen, C. Difficile
Applicant	UNIPATH LTD. NORSE ROAD BEDFORD MK41 OQG GB Other 510(k) Applications for this Company
Contact	Louise Roberts Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	MCB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/1995
Decision Date	09/13/1996
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