510(k) K203833 ยท MLM Enzyme Immunoassay, Tracrolimus
Tacrolimus Assay Kit
| Applicant | Shanghai Genext Medical Technology Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jan 27, 2023 |
| Received | Dec 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203833
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.