510(k) K240124 · DJG Enzyme Immunoassay, Opiates
BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jun 14, 2024 |
| Received | Jan 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240124
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.