FDA 510(k) Application Details - K992587

Device Classification Name	Epstein-Barr Virus, Other   More FDA Info for this Device
510(K) Number	K992587
Device Name	Epstein-Barr Virus, Other
Applicant	STELLAR BIO SYSTEMS, INC. 9075 GUILFORD RD. COLUMBIA, MD 21046 US Other 510(k) Applications for this Company
Contact	JOHN BREWER 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	08/02/1999
Decision Date	12/22/1999
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