Cleared Traditional

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

K932980 · Sigma Diagnostics, Inc. · Chemistry
Oct 1993
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K932980 is an FDA 510(k) clearance for the TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116, a Radioimmunoassay, Total Thyroxine (Class II — Special Controls, product code CDX), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 18, 1993, 123 days after receiving the submission on June 17, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K932980 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1993
Decision Date October 18, 1993
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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