Cleared Traditional

COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE

K020920 · Cozart Bioscience , Ltd. · Toxicology
Nov 2002
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K020920 is an FDA 510(k) clearance for the COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on November 5, 2002, 229 days after receiving the submission on March 21, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K020920 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2002
Decision Date November 05, 2002
Days to Decision 229 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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