510(k) K811459 ยท LAO Enzyme Immunoassay, Methotrexate
EMIT-AND METHOTREXATE ASSAY
| Applicant | Syva Co., Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 9, 1981 |
| Received | May 26, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | Siemens Healthcare Diagnostics, Inc. Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma. Terminated |
LAO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.