510(k) K231904 ยท DJG Enzyme Immunoassay, Opiates
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Mar 8, 2024 |
| Received | Jun 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231904
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.