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 Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
FDA 510(k) clearance K240949 · decided 2024-05-13
Clearance details
- K-number
- K240949
- Device name
- 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 Rapid Test Strip (Urine); Healgen® Accurate Rapid Fentanyl Test Strip (Urine)
- Applicant
- Healgen Scientific,, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-04-08
- Decision date
- 2024-05-13
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- NGL
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K253567) | Healgen Scientific,, LLC | 2025-12-23 |
| Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (K250803) | Anhui Deepblue Medical Technological Co., Ltd. | 2025-04-15 |
| Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-02-20 |
| 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. | 2025-02-06 |
| Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (K243365) | Healgen Scientific,, LLC | 2024-12-17 |
| ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test (K243064) | Eterbio, Inc. | 2024-11-20 |
| CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette (K242802) | Hangzhou Clongene Biotech Co., Ltd. | 2024-11-08 |
| BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader (K241869) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-10-04 |
| Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969) | Qingdao Hightop Biotech Co., Ltd. | 2024-08-14 |
| SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel (K241741) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-07-16 |
| Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (K241100) | Co-Innovation Biotech Co., Ltd. | 2024-05-22 |
| Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card (K240686) | Healgen Scientific,, LLC | 2024-04-12 |
Recalls involving this device
No recalls on record reference this clearance.