FDA 510(k) Application Details - K973939

Device Classification Name	Antibody Igm, If, Epstein-Barr Virus   More FDA Info for this Device
510(K) Number	K973939
Device Name	Antibody Igm, If, Epstein-Barr Virus
Applicant	GenBio 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US Other 510(k) Applications for this Company
Contact	Bryan Kiehl Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/1997
Decision Date	08/10/1998
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