IMMUNODOT MONO-G TEST

Epstein-barr Virus, Other

GenBio

The following data is part of a premarket notification filed by Genbio with the FDA for Immunodot Mono-g Test.

Pre-market Notification Details

Device IDK974226
510k NumberK974226
Device Name:IMMUNODOT MONO-G TEST
ClassificationEpstein-barr Virus, Other
Applicant GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego,  CA  92128
ContactBryan Kiehl
CorrespondentBryan Kiehl
GenBio 15222 AVE. OF SCIENCE, SUITE A San Diego,  CA  92128
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-12
Decision Date1998-09-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.