Cleared Traditional

BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST

K002264 · Branan Medical Corporation · Toxicology
Nov 2000
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K002264 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on November 27, 2000, 125 days after receiving the submission on July 25, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K002264 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2000
Decision Date November 27, 2000
Days to Decision 125 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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