Panels › Clinical Toxicology › Product code POX · Class 2
Enzyme Immunoassay, Oxcarbazepine Metabolite
Regulation 862.3645
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in POX
| Company | 510(k)s | Recalls |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 2016 | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control Ark Diagnostics, Inc. | POX |
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