Cleared Traditional

TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA

K971779 · Monobind · Chemistry
Jun 1997
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K971779 is an FDA 510(k) clearance for the TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Monobind (Costa Mesa, US). The FDA issued a Cleared decision on June 16, 1997, 33 days after receiving the submission on May 14, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.

Submission Details

510(k) Number K971779 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1997
Decision Date June 16, 1997
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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