Cleared Traditional

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. · Toxicology
Dec 2023
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K233019 is an FDA 510(k) clearance for the 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, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 13, 2023, 82 days after receiving the submission on September 22, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K233019 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2023
Decision Date December 13, 2023
Days to Decision 82 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
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
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
K182738 · Hangzhou AllTest Biotech Co., Ltd. · Mar 2019