510(k) K261280 ยท NFT Test, Amphetamine, Over The Counter
BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Apr 17, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261280
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.