GAMMA STIK 125I T3 UPTAKE KIT

Radioimmunoassay, Total Triiodothyronine

ALPHA GAMMA LABORATORY

The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stik 125i T3 Uptake Kit.

Pre-market Notification Details

Device IDK780492
510k NumberK780492
Device Name:GAMMA STIK 125I T3 UPTAKE KIT
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-27
Decision Date1978-04-28

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