Cleared Traditional

GAMMA STIK 125I T3 UPTAKE KIT

K780492 · Alpha Gamma Laboratory · Chemistry
Apr 1978
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K780492 is an FDA 510(k) clearance for the GAMMA STIK 125I T3 UPTAKE KIT, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Alpha Gamma Laboratory (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978, 32 days after receiving the submission on March 27, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K780492 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1978
Decision Date April 28, 1978
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDP — Radioimmunoassay, Total Triiodothyronine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1710

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