MEASLES VIRUS RUBEOLA

Antigen, Cf, (including Cf Control), Rubeola

INSTITUTE VIRION LTD.

The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Measles Virus Rubeola.

Pre-market Notification Details

Device IDK843662
510k NumberK843662
Device Name:MEASLES VIRUS RUBEOLA
ClassificationAntigen, Cf, (including Cf Control), Rubeola
Applicant INSTITUTE VIRION LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGRJ  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-17
Decision Date1985-09-26

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