PROLACTIN (125) RADIOIMMUNAOASSAY

Radioimmunoassay, Prolactin (lactogen)

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Prolactin (125) Radioimmunaoassay.

Pre-market Notification Details

Device IDK803273
510k NumberK803273
Device Name:PROLACTIN (125) RADIOIMMUNAOASSAY
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant CORNING MEDICAL & SCIENTIFIC 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 Received1980-12-29
Decision Date1981-01-16

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