FDA 510(k) Application Details - K981829

Device Classification Name	Antiserum, Cf, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K981829
Device Name	Antiserum, Cf, Epstein-Barr Virus
Applicant	DIAMEDIX CORP. 8775 M CENTRE PARK DR. #559 COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	NORMAN JENKINS Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	GNP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/1998
Decision Date	02/16/1999
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