Cleared Traditional

REAGENT, THYROXINE T4 (#210)

K760079 · Oxford Laboratories, Inc. · Chemistry
Jul 1976
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K760079 is an FDA 510(k) clearance for the REAGENT, THYROXINE T4 (#210), a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Oxford Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 32 days after receiving the submission on June 18, 1976. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K760079 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1976
Decision Date July 20, 1976
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDX — Radioimmunoassay, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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