EB-VCA, TEST, ANTIBODY, FLUORESCENT

Antiserum, Fluorescent, Epstein-barr Virus

LITTON BIONETICS

The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Eb-vca, Test, Antibody, Fluorescent.

Pre-market Notification Details

Device IDK780925
510k NumberK780925
Device Name:EB-VCA, TEST, ANTIBODY, FLUORESCENT
ClassificationAntiserum, Fluorescent, Epstein-barr Virus
Applicant LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJRY  
CFR Regulation Number866.3235 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-06
Decision Date1978-06-22

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