510(k) K163359 ยท LAO Enzyme Immunoassay, Methotrexate
ARK Methotrexate Assay
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Aug 18, 2017 |
| Received | Nov 30, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163359
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.