FDA 510(k) Application Details - K030992

Device Classification Name	Reagents, Clostridium Difficile Toxin   More FDA Info for this Device
510(K) Number	K030992
Device Name	Reagents, Clostridium Difficile Toxin
Applicant	TECHLAB, INC. 1861 PRATT DR., STE. 1030 BLACKSBURG, VA 24060-6364 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	LLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2003
Decision Date	07/11/2003
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