NGL — Test, Opiates, Over The Counter Class II
FDA product code NGL covers "Test, Opiates, Over The Counter", a Class II medical device regulated under 21 CFR 862.3650. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NGL
- Device Class
- Class II
- Regulation Number
- 862.3650
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253567 | healgen scientific | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te | December 23, 2025 |
| K250803 | anhui deepblue medical technological co | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup | April 15, 2025 |
| K250067 | guangzhou decheng biotechnology co | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro | February 20, 2025 |
| K242428 | guangzhou decheng biotechnology co | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Doche | February 6, 2025 |
| K243365 | healgen scientific | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Dru | December 17, 2024 |
| K243064 | eterbio | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfe | November 20, 2024 |
| K242802 | hangzhou clongene biotech co | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | November 8, 2024 |
| K241869 | vivachek biotech (hangzhou) co | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSi | October 4, 2024 |
| K241969 | qingdao hightop biotech co | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl | August 14, 2024 |
| K241741 | guangzhou wondfo biotech co | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Te | July 16, 2024 |
| K241100 | co-innovation biotech co | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | May 22, 2024 |
| K240949 | healgen scientific | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid | May 13, 2024 |
| K240686 | healgen scientific | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Te | April 12, 2024 |
| K240654 | safecare biotech (hangzhou) co | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | April 10, 2024 |
| K240295 | instanosis | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine | March 28, 2024 |
| K234006 | allsource screening solutions | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | March 21, 2024 |
| K240351 | assure tech | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Uri | March 6, 2024 |
| K233417 | hangzhou alltest biotech co | AllTest Fentanyl Urine Test Cassette | October 26, 2023 |
| K193480 | shenzhen bioeasy biotechnology co | BIOEASY Multi-Drug Test Cup | January 31, 2020 |
| K190412 | hangzhou clongene biotech co | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup | March 21, 2019 |