Cleared Traditional

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)

K152269 · Healgen Scientific, LLC · Toxicology
Sep 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K152269 is an FDA 510(k) clearance for the Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card), a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on September 9, 2015, 29 days after receiving the submission on August 11, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K152269 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2015
Decision Date September 09, 2015
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

Similar Devices — DKZ Enzyme Immunoassay, Amphetamine

All 224
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
Quidel Triage? TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600; Quidel Triage? MeterPro
K182719 · Quidel Cardiovascular, Inc. · Jun 2019

More from Healgen Scientific, LLC

View all
Healgen? Accurate Oral Fluid Drug Test COT/THC; Healgen? Accurate Oral Fluid Drug Test
K252523 · NFW · Feb 2026
Healgen? URS Test Strips
K251800 · JMT · Dec 2025
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
K253567 · NGL · Dec 2025
Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180)
K251972 · DJG · Aug 2025
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
K243365 · NGL · Dec 2024