510(k) K153596 ยท POX Enzyme Immunoassay, Oxcarbazepine Metabolite
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
| Applicant | Ark Diagnostics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Aug 9, 2016 |
| Received | Dec 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153596
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.