EBNA-1 IGM ELISA TEST SYSTEM

Epstein-barr Virus, Other

COLUMBIA BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Columbia Bioscience, Inc. with the FDA for Ebna-1 Igm Elisa Test System.

Pre-market Notification Details

Device IDK982348
510k NumberK982348
Device Name:EBNA-1 IGM ELISA TEST SYSTEM
ClassificationEpstein-barr Virus, Other
Applicant COLUMBIA BIOSCIENCE, INC. 8775 M CENTRE PARK DR. #559 Columbia,  MD  21045
ContactNorman Jenkins
CorrespondentNorman Jenkins
COLUMBIA BIOSCIENCE, INC. 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 Received1998-07-06
Decision Date1998-11-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B3507206300 K982348 000

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