FDA 510(k) Application Details - K980077

Device Classification Name	Device, Parasite Concentration   More FDA Info for this Device
510(K) Number	K980077
Device Name	Device, Parasite Concentration
Applicant	MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	ALLAN D NICKOL Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LKS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/1998
Decision Date	04/02/1998
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