Cleared Traditional

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

K950135 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Mar 1995
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K950135 is an FDA 510(k) clearance for the URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 30, 1995, 76 days after receiving the submission on January 13, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K950135 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1995
Decision Date March 30, 1995
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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