FDA 510(k) Application Details - K983841

Device Classification Name	Epstein-Barr Virus, Other   More FDA Info for this Device
510(K) Number	K983841
Device Name	Epstein-Barr Virus, Other
Applicant	BIOTEST DIAGNOSTICS CORP. 66 FORD RD., SUITE 131 DENVILLE, NJ 07834 US Other 510(k) Applications for this Company
Contact	PATRICIA E BONNESS Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/1998
Decision Date	06/09/1999
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