Cleared Traditional

WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST

K112395 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology
Sep 2011
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K112395 is an FDA 510(k) clearance for the WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST, a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG), submitted by Guangzhou Wondfo Biotech Co., Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on September 9, 2011, 21 days after receiving the submission on August 19, 2011. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K112395 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2011
Decision Date September 09, 2011
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.

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