IMMUNOWELL EBV VCA IGG TEST

Epstein-barr Virus, Other

GenBio

The following data is part of a premarket notification filed by Genbio with the FDA for Immunowell Ebv Vca Igg Test.

Pre-market Notification Details

Device IDK973940
510k NumberK973940
Device Name:IMMUNOWELL EBV VCA IGG 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 Received1997-10-15
Decision Date1998-08-10
Summary:summary

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