RUBENOSTICON

Antisera, Hai (including Hai Control), Rubella

ORGANON, INC.

The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Rubenosticon.

Pre-market Notification Details

Device IDK780063
510k NumberK780063
Device Name:RUBENOSTICON
ClassificationAntisera, Hai (including Hai Control), Rubella
Applicant ORGANON, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGOK  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-01-12
Decision Date1978-01-20

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