510(k) K241969 · NGL Test, Opiates, Over The Counter
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
| Applicant | Qingdao Hightop Biotech Co., Ltd., Qingdao, CN |
| Decision | Substantially Equivalent, Aug 14, 2024 |
| Received | Jul 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241969
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.