NGL
- Product code
- NGL
- Device name
- Test, Opiates, Over The Counter
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.3650
- Medical specialty
- Clinical Toxicology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 18
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 23 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (18)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253567 | 2025-12-23 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen… | |
| K250803 | 2025-04-15 | Anhui Deepblue Medical Technological C… | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Mu… | |
| K250067 | 2025-02-20 | Guangzhou Decheng Biotechnology Co., L… | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Dru… | |
| K242428 | 2025-02-06 | Guangzhou Decheng Biotechnology Co., L… | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl … | |
| K243365 | 2024-12-17 | Healgen Scientific,, LLC | Healgen Accurate Muti-Drug Urine Drug Screen Cup; He… | |
| K243064 | 2024-11-20 | Eterbio, Inc. | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal G… | |
| K242802 | 2024-11-08 | Hangzhou Clongene Biotech Co., Ltd. | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fenta… | |
| K241869 | 2024-10-04 | Vivachek Biotech (Hangzhou) Co., Ltd. | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fent… | |
| K241969 | 2024-08-14 | Qingdao Hightop Biotech Co., Ltd. | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid T… | FDA |
| K241741 | 2024-07-16 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife Fentanyl Urine Home Test (Cassette); SAFEl… | FDA |
| K241100 | 2024-05-22 | Co-Innovation Biotech Co., Ltd. | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine F… | |
| K240949 | 2024-05-13 | Healgen Scientific,, LLC | Healgen® Accurate Fentanyl Rapid Test Cassette (Urin… | |
| K240686 | 2024-04-12 | Healgen Scientific,, LLC | Healgen Accurate Urine Drug Screen Dip Card; Healgen… | FDA |
| K240654 | 2024-04-10 | Safecare Biotech (Hangzhou) Co., Ltd. | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL … | |
| K240295 | 2024-03-28 | Instanosis, Inc. | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip F… | |
| K234006 | 2024-03-21 | Allsource Screening Solutions | AllSource Drug Detector FenTest; AllSource Drug Dete… | |
| K240351 | 2024-03-06 | Assure Tech., LLC | FaStep Fentanyl Rapid Test Device (Urine); FaStep Ra… | |
| K233417 | 2023-10-26 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Fentanyl Urine Test Cassette |
Official FDA classification page: NGL
Classification and pathway per current FDA publications. Data from openFDA (CC0).