Cleared Traditional

WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)

K132630 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Sep 2013
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K132630 is an FDA 510(k) clearance for the WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300), a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on September 27, 2013, 36 days after receiving the submission on August 22, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K132630 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2013
Decision Date September 27, 2013
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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