IS EBV-EA-D IGG ELISA TEST SYSTEM

Antiserum, Cf, Epstein-barr Virus

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK981831
510k NumberK981831
Device Name:IS EBV-EA-D IGG ELISA TEST SYSTEM
ClassificationAntiserum, Cf, Epstein-barr Virus
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 CodeGNP  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-22
Decision Date1999-02-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020358 K981831 000
B3507206400 K981831 000

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