MAGIC T4 125I RADIOIMMUNOASSAY

Radioimmunoassay, Total Thyroxine

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic T4 125i Radioimmunoassay.

Pre-market Notification Details

Device IDK831533
510k NumberK831533
Device Name:MAGIC T4 125I RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Total Thyroxine
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-13
Decision Date1983-06-30

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