K241969
- 510(k) number
- K241969
- Device name
- Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
- Applicant
- Qingdao Hightop Biotech Co., Ltd. CN
- Product code
- NGL — Test, Opiates, Over The Counter
- Decision date
- 2024-08-14
- Date received
- 2024-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
510(k) Summary (official FDA PDF): K241969.pdf
Official FDA record: K241969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.