FDA 510(k) Application Details - K053572

Device Classification Name	Antigen, C. Difficile   More FDA Info for this Device
510(K) Number	K053572
Device Name	Antigen, C. Difficile
Applicant	TECHLAB, INC. 2001 KRAFT DR. BLACKSBURG, VA 24060-6358 US Other 510(k) Applications for this Company
Contact	DAVID M LYERLY 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	12/22/2005
Decision Date	04/26/2006
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