EBV-VCA IGG ELISA TEST SYSTEM

Epstein-barr Virus, Other

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Ebv-vca Igg Elisa Test System.

Pre-market Notification Details

Device IDK981812
510k NumberK981812
Device Name:EBV-VCA IGG ELISA TEST SYSTEM
ClassificationEpstein-barr Virus, Other
Applicant DIAMEDIX CORP. 8775 M CENTRE PARK DR. #559 Columbia,  MD  21045
ContactNorman Jenkins
CorrespondentNorman Jenkins
DIAMEDIX CORP. 8775 M CENTRE PARK DR. #559 Columbia,  MD  21045
Product CodeLSE  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-22
Decision Date1999-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020334 K981812 000
B3507206000 K981812 000

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