510(k) K243462 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
Diazyme Colorimetric Lithium Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Aug 1, 2025 |
| Received | Nov 8, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243462
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.