RIANEN PROLACTIN 125I KIT

Radioimmunoassay, Prolactin (lactogen)

NEW ENGLAND NUCLEAR

The following data is part of a premarket notification filed by New England Nuclear with the FDA for Rianen Prolactin 125i Kit.

Pre-market Notification Details

Device IDK831345
510k NumberK831345
Device Name:RIANEN PROLACTIN 125I KIT
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant NEW ENGLAND NUCLEAR 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-25
Decision Date1983-06-08

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