Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
FDA 510(k) K241100 · Co-Innovation Biotech Co., Ltd.
510(k) numberK241100
Submission
- Device name
- Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
- Applicant
- Co-Innovation Biotech Co., Ltd.
Guangzhou, CN - Received
- April 22, 2024
- Decision date
- May 22, 2024
- 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 |
| K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProNGL · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 02/20/2025SE |
| 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 |
More from Guangzhou Wondfo Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | 03/08/2024SE |
| K232732 | Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional | 01/17/2024SE |
| K213808 | Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…LCX · Special | 04/05/2022SE |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJG · Special | 04/26/2016SE |
| K142800 | Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test DipcardDKZ · Traditional | 12/11/2014SE |
| K140748 | One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardDJG · Traditional | 08/20/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | 06/16/2014SE |
| K131110 | One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test DipcardDKZ · Traditional | 01/15/2014SE |
| K132085 | One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test MidstreamLCX · Traditional | 11/12/2013SE |
Questions and answers
When was Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard cleared by the FDA?
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard (K241100) received a 510(k) decision of Substantially Equivalent on May 22, 2024, 30 days after the submission was received.
What is the product code of K241100?
The FDA product code is NGL – Test, Opiates, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3650.