Qingdao Hightop Biotech Co., Ltd. · Class II · Cleared Aug 14, 2024
| 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. |
| Product code | NGL |
| Device class | Class II |
| Decision date | Aug 14, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 862.3650 |
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