Cleared Traditional

THERAPEUTIC DRUG CONTROL

K833761 · Icl Scientific · Toxicology
Jan 1984
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K833761 is an FDA 510(k) clearance for the THERAPEUTIC DRUG CONTROL, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984, 79 days after receiving the submission on October 26, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K833761 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1983
Decision Date January 13, 1984
Days to Decision 79 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKB — Calibrators, Drug Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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