Cleared Traditional

FEKAL CON-TRATE SYSTEM

K830769 · Trend Scientific, Inc. · Chemistry
Apr 1983
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K830769 is an FDA 510(k) clearance for the FEKAL CON-TRATE SYSTEM, a Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (Class II — Special Controls, product code KLI), submitted by Trend Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1983, 25 days after receiving the submission on March 11, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1700.

Submission Details

510(k) Number K830769 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1983
Decision Date April 05, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLI — Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1700

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