FDA 510(k) Application Details - K980507

Device Classification Name	Antigens, All Types, Escherichia Coli   More FDA Info for this Device
510(K) Number	K980507
Device Name	Antigens, All Types, Escherichia Coli
Applicant	ALEXON - TREND, INC. 14000 UNITY ST., N.W. RAMSEY, MN 55303-9115 US Other 510(k) Applications for this Company
Contact	BARBARA A CHIPONIS, MT (ASCP) 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	02/10/1998
Decision Date	04/23/1998
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