FDA 510(k) Application Details - K982315

Device Classification Name	Campylobacter Spp.   More FDA Info for this Device
510(K) Number	K982315
Device Name	Campylobacter Spp.
Applicant	ALEXON - TREND, INC. 14000 UNITY ST., N.W. RAMSEY, MN 55303-9115 US Other 510(k) Applications for this Company
Contact	KEN HOOD Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/1998
Decision Date	11/18/1998
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