Cleared Traditional

DRUGS OF ABUSE CALIBRATOR

K950139 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Feb 1995
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K950139 is an FDA 510(k) clearance for the DRUGS OF ABUSE CALIBRATOR, a Calibrators, Drug Mixture (Class II — Special Controls, product code DKB), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 22, 1995, 40 days after receiving the submission on January 13, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K950139 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1995
Decision Date February 22, 1995
Days to Decision 40 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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