Cleared Traditional

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE

K950182 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology

Mar 1995

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K950182 is an FDA 510(k) clearance for the URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE, a Hemagglutination Inhibition, Methadone (Class II — Special Controls, product code DIW), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 21, 1995, 63 days after receiving the submission on January 17, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number	K950182 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 1995
Decision Date	March 21, 1995
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF