FDA 510(k) Application Details - K121364

Device Classification Name	Antigens, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K121364
Device Name	Antigens, All Types, Escherichia Coli
Applicant	TECHLAB INC., CORPORATE RESEARCH CENTER 2001 KRAFT DR. BLACKSBURG, VA 24060-6358 US Other 510(k) Applications for this Company
Contact	DONNA T LINK Other 510(k) Applications for this Contact
Regulation Number	866.3255   More FDA Info for this Regulation Number
Classification Product Code	GMZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2012
Decision Date	10/02/2012
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