RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

Antigen, Ha (including Ha Control), Rubella

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Rubella Elisa Reagents Rubella Igg Anti.

Pre-market Notification Details

Device IDK802102
510k NumberK802102
Device Name:RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
ClassificationAntigen, Ha (including Ha Control), Rubella
Applicant CALBIOCHEM-BEHRING CORP. 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 Received1980-09-03
Decision Date1980-12-18

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