510(k) K261409 · NFT Test, Amphetamine, Over The Counter
BioTeke® Multi-Drug Urine Test Cup
| Applicant | Bioteke Corporation (Wuxi) Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Sep 10, 2026 |
| Received | Apr 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261409
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.