Cleared Traditional

T3 RIA TEST SYSTEM

K771220 · Monobind · Chemistry
Aug 1977
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K771220 is an FDA 510(k) clearance for the T3 RIA TEST SYSTEM, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977, 30 days after receiving the submission on July 5, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K771220 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 1977
Decision Date August 04, 1977
Days to Decision 30 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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