Cleared Traditional

METHADONE MICROPLATE EIA URINE APPLICATION

K011131 · Cozart Bioscience , Ltd. · Toxicology
Jul 2001
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K011131 is an FDA 510(k) clearance for the METHADONE MICROPLATE EIA URINE APPLICATION, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Cozart Bioscience , Ltd. (Oxfordshire Ox14 4ru, GB). The FDA issued a Cleared decision on July 31, 2001, 109 days after receiving the submission on April 13, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.

Submission Details

510(k) Number K011131 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2001
Decision Date July 31, 2001
Days to Decision 109 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJR — Enzyme Immunoassay, Methadone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3620

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