Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
FDA 510(k) K250067 · Guangzhou Decheng Biotechnology Co., Ltd.
510(k) numberK250067
Submission
- Device name
- Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd.
Guangzhou, CN - Received
- January 10, 2025
- Decision date
- February 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGL – Test, Opiates, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip…NGL · Traditional | Healgen Scientific,, LLC | 12/23/2025SE |
| K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupNGL · Traditional | Anhui Deepblue Medical Technological Co., Ltd. | 04/15/2025SE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…NGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/06/2025SE |
| K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine…NGL · Traditional | Healgen Scientific,, LLC | 12/17/2024SE |
| K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…NGL · Traditional | Eterbio, Inc. | 11/20/2024SE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 11/08/2024SE |
| K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve…NGL · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 10/04/2024SE |
| K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…NGL · Traditional | Qingdao Hightop Biotech Co., Ltd. | 08/14/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 07/16/2024SE |
| K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGL · Traditional | Co-Innovation Biotech Co., Ltd. | 05/22/2024SE |
More from Co-Innovation Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | 09/09/2025SE |
| K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…NGL · Traditional | 02/06/2025SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | 06/21/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | 05/10/2024SE |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupDJG · Traditional | 12/13/2023SE |
| K230038 | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCX · Traditional | 02/28/2023SE |
| K222305 | MissLan Digital Pregnancy Rapid TestLCX · Traditional | 11/30/2022SE |
Questions and answers
When was Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro cleared by the FDA?
Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (K250067) received a 510(k) decision of Substantially Equivalent on February 20, 2025, 41 days after the submission was received.
What is the product code of K250067?
The FDA product code is NGL – Test, Opiates, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3650.