Cleared Traditional

URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE

K950137 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Apr 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K950137 is an FDA 510(k) clearance for the URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 13, 1995, 90 days after receiving the submission on January 13, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K950137 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1995
Decision Date April 13, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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