K241741
- 510(k) number
- K241741
- Device name
- 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
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-07-16
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
510(k) Summary (official FDA PDF): K241741.pdf
Official FDA record: K241741
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.