510(k) K111904 ยท LAO Enzyme Immunoassay, Methotrexate
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
| Applicant | Ark Diagnostics, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 18, 2011 |
| Received | Jul 5, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111904
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.