ENI ANTIBODY TO EPSTEIN-BARR VIRUS

Antiserum, Cf, Epstein-barr Virus

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Eni Antibody To Epstein-barr Virus.

Pre-market Notification Details

Device IDK810860
510k NumberK810860
Device Name:ENI ANTIBODY TO EPSTEIN-BARR VIRUS
ClassificationAntiserum, Cf, Epstein-barr Virus
Applicant ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGNP  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-30
Decision Date1981-05-05

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