RIANEN ESTRIOL RADIOIMMUNOASSAY KIT

Radioimmunoassay, Estriol

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Estriol Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK840301
510k NumberK840301
Device Name:RIANEN ESTRIOL RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Estriol
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGI  
CFR Regulation Number862.1265 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-24
Decision Date1984-03-30

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