510(k) K252554 ยท NFT Test, Amphetamine, Over The Counter
Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Sep 12, 2025 |
| Received | Aug 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252554
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.