Cleared Traditional

URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE

K950134 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology

Mar 1995

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K950134 is an FDA 510(k) clearance for the URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE, a Hemagglutination, Cocaine Metabolites (benzoylecgnonine) (Class II — Special Controls, product code DLN), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 21, 1995, 67 days after receiving the submission on January 13, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number	K950134 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1995
Decision Date	March 21, 1995
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF