FDA 510(k) Application Details - K982764

Device Classification Name	Cryptosporidium Spp.   More FDA Info for this Device
510(K) Number	K982764
Device Name	Cryptosporidium 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	MHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/1998
Decision Date	12/03/1998
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