Cleared Traditional

AllTest Fentanyl Urine Test Cassette

K233417 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology
Oct 2023
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K233417 is an FDA 510(k) clearance for the AllTest Fentanyl Urine Test Cassette, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 26, 2023, 16 days after receiving the submission on October 10, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K233417 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2023
Decision Date October 26, 2023
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code NGL — Test, Opiates, Over The Counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

Similar Devices — NGL Test, Opiates, Over The Counter

All 22
Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
K253567 · Healgen Scientific, LLC · Dec 2025
Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
K250803 · Anhui Deepblue Medical Technological Co., Ltd. · Apr 2025
Dochek? Multi-Drug Urine Test Cup; Dochek? Multi-Drug Urine Test Cup Pro
K250067 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
Dochek? Fentanyl Urine Test Strip, Dochek? Fentanyl Urine Test Strip Plus, Dochek? Fentanyl Urine Test Card, Dochek? Fentanyl Urine Test Card Plus, Dochek? Fentanyl Urine Test Cup and Dochek? Fentanyl Urine Test Cup Plus
K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
K243365 · Healgen Scientific, LLC · Dec 2024
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
K243064 · Eterbio, Inc. · Nov 2024