Cleared Traditional

URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE

K950181 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Apr 1995
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K950181 is an FDA 510(k) clearance for the URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 5, 1995, 78 days after receiving the submission on January 17, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K950181 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1995
Decision Date April 05, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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