Cleared Traditional

URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

K950136 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Apr 1995
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K950136 is an FDA 510(k) clearance for the URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 5, 1995, 82 days after receiving the submission on January 13, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K950136 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1995
Decision Date April 05, 1995
Days to Decision 82 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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