510(k) K241869 · NGL Test, Opiates, Over The Counter
BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Oct 4, 2024 |
| Received | Jun 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241869
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.