Cleared Traditional

MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23

K030113 · Branan Medical Corp. · Toxicology
Jul 2003
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K030113 is an FDA 510(k) clearance for the MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on July 2, 2003, 170 days after receiving the submission on January 13, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K030113 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2003
Decision Date July 02, 2003
Days to Decision 170 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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