ANTIBODY TO RUBELLA VIRUS

Antisera, Hai (including Hai Control), Rubella

ELECTRO-NUCLEONICS LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK792635
510k NumberK792635
Device Name:ANTIBODY TO RUBELLA VIRUS
ClassificationAntisera, Hai (including Hai Control), Rubella
Applicant ELECTRO-NUCLEONICS LABORATORIES, 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 Received1979-12-19
Decision Date1980-03-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G5229027011 K792635 000
G5229027001 K792635 000

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