Ark Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories7
Latest Approval2024-02-27
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K232522 | ARK Levetiracetam II Assay | ORI | 2024-02-27 | View |
| 510(k) | K232017 | ARK Methotrexate II Assay | LAO | 2023-12-20 | View |
| 510(k) | K231752 | ARK Hydrocodone Assay | DJG | 2023-11-09 | View |
| 510(k) | K201089 | ARK Lacosamide Assay | NWM | 2021-08-05 | View |
| 510(k) | K200197 | ARK Fentanyl II Assay | DJG | 2020-02-26 | View |
| 510(k) | K182280 | ARK Tramadol Assay | DJG | 2018-12-10 | View |
| 510(k) | K182779 | ARK EDDP Assay | DJR | 2018-11-21 | View |
| 510(k) | K180427 | ARK Fentanyl Assay | DJG | 2018-06-06 | View |
| 510(k) | K163359 | ARK Methotrexate Assay | LAO | 2017-08-18 | View |
| 510(k) | DEN160033 | ARK Voriconazole II Assay Test System | PUJ | 2017-05-05 | View |
| 510(k) | K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | POX | 2016-08-09 | View |
No matching devices.