510(k) K101305 ยท ORH Lamotrigine Assay
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
| Applicant | Ark Diagnostics, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 29, 2010 |
| Received | May 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101305
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.