FDA 510(k) Application Details - K982711

Device Classification Name	Giardia Spp.   More FDA Info for this Device
510(K) Number	K982711
Device Name	Giardia Spp.
Applicant	MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	ALLEN D NICKOL Other 510(k) Applications for this Contact
Regulation Number	866.3220   More FDA Info for this Regulation Number
Classification Product Code	MHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1998
Decision Date	11/25/1998
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