FDA 510(k) Applications for Medical Device Product Code "NGL"
(Test, Opiates, Over The Counter)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K234006 | AllSource Screening Solutions | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | 03/21/2024 |
| K082898 | AMEDICA BIOTECH, INC. | AMEDICA DRUG SCREEN TEST CUP | 12/19/2008 |
| K100108 | AMEDICA BIOTECH, INC. | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA | 04/14/2010 |
| K250803 | ANHUI Deepblue Medical Technological Co., Ltd. | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | 04/15/2025 |
| K240351 | Assure Tech LLC | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | 03/06/2024 |
| K241100 | Co-Innovation Biotech Co.,Ltd. | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | 05/22/2024 |
| K243064 | Eterbio, Inc. | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test | 11/20/2024 |
| K242428 | Guangzhou Decheng Biotechnology Co., Ltd. | 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 | 02/06/2025 |
| K250067 | Guangzhou Decheng Biotechnology Co., Ltd. | Dochek« Multi-Drug Urine Test Cup; Dochek« Multi-Drug Urine Test Cup Pro | 02/20/2025 |
| K241741 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElifeÖ Fentanyl Urine Home Test (Cassette); SAFElifeÖ Fentanyl (FTY) Urine Test Cassette; SAFElifeÖ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElifeÖ T-Dip Fentanyl (FTY) Urine Test Panel | 07/16/2024 |
| K233417 | Hangzhou AllTest Biotech Co.,Ltd | AllTest Fentanyl Urine Test Cassette | 10/26/2023 |
| K242802 | Hangzhou Clongene Biotech Co.,Ltd. | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | 11/08/2024 |
| K181790 | Hangzhou Clongene Biotech Co.,Ltd. | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | 07/26/2018 |
| K190412 | Hangzhou Clongene Biotech Co.,Ltd. | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | 03/21/2019 |
| K243365 | Healgen Scientific LLC | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup | 12/17/2024 |
| K240686 | Healgen Scientific LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | 04/12/2024 |
| K240949 | Healgen Scientific LLC | Healgen« Accurate Fentanyl Rapid Test Cassette (Urine); Healgen« Accurate Rapid Fentanyl Test Cassette (Urine); Healgen« Accurate Fentanyl Rapid Test Dip Card (Urine); Healgen« Accurate Rapid Fentanyl Test Dip Card (Urine); Healgen« Accurate Fentanyl Rapi | 05/13/2024 |
| K240295 | Instanosis Inc | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | 03/28/2024 |
| K241969 | Qingdao HIGHTOP Biotech Co., Ltd. | Hightop« Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop« Fentanyl/Norfentanyl Urine Rapid Test Panel | 08/14/2024 |
| K240654 | Safecare Biotech (Hangzhou) Co., Ltd. | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | 04/10/2024 |
| K193480 | Shenzhen Bioeasy Biotechnology Co.,Ltd. | BIOEASY Multi-Drug Test Cup | 01/31/2020 |
| K241869 | VivaChek Biotech (Hangzhou) Co., Ltd | BioSieveÖ Fentanyl FIA Home Test Kit; BioSieveÖ Fentanyl FIA Pro Test Kit; BioSieveÖ Toxismart Reader | 10/04/2024 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
