RUBELLA BIO-BEAD SCREEN KIT

Antigen, Ha (including Ha Control), Rubella

LITTON BIONETICS

The following data is part of a premarket notification filed by Litton Bionetics with the FDA for Rubella Bio-bead Screen Kit.

Pre-market Notification Details

Device IDK791610
510k NumberK791610
Device Name:RUBELLA BIO-BEAD SCREEN KIT
ClassificationAntigen, Ha (including Ha Control), Rubella
Applicant LITTON BIONETICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGOL  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-21
Decision Date1979-11-13

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