Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel— 510(k) K241969
Substantially EquivalentQingdao Hightop Biotech Co., Ltd.
FDA 510(k) clearance K241969 for Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel, Substantially Equivalent on 2024-08-14. Applicant: Qingdao Hightop Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Qingdao Hightop Biotech Co., Ltd.
- Product code
- Code NGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.3650
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Qingdao, CN
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More clearances from Qingdao Hightop Biotech Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.