EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

Test, Antigen, Nuclear, Epstein-barr Virus

BION ENT., LTD.

The following data is part of a premarket notification filed by Bion Ent., Ltd. with the FDA for Epstein-barr Virus-nuclear Antigen.

Pre-market Notification Details

Device IDK894626
510k NumberK894626
Device Name:EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN
ClassificationTest, Antigen, Nuclear, Epstein-barr Virus
Applicant BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
ContactJudy Mccormack
CorrespondentJudy Mccormack
BION ENT., LTD. 674 BUSSE HWY. Park Ridge,  IL  60068
Product CodeLLM  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-10-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B110NA51400 K894626 000
B110NA51120 K894626 000

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