FDA 510(k) Application Details - K951822

Device Classification Name	Test, Antigen, Nuclear, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K951822
Device Name	Test, Antigen, Nuclear, Epstein-Barr Virus
Applicant	GRANBIO, INC. 38660 DE PORTOLA RD. P.O. BOX 892140 TEMECULA, CA 92589 US Other 510(k) Applications for this Company
Contact	DAVID J GRANLUND Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LLM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/1995
Decision Date	02/15/1996
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