Cleared Traditional

Wondfo Propoxyphene Urine Test

K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Nov 2015
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K152495 is an FDA 510(k) clearance for the Wondfo Propoxyphene Urine Test, a Enzyme Immunoassay, Propoxyphene (Class II — Special Controls, product code JXN), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 23, 2015, 83 days after receiving the submission on September 1, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3700.

Submission Details

510(k) Number K152495 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2015
Decision Date November 23, 2015
Days to Decision 83 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXN — Enzyme Immunoassay, Propoxyphene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3700

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