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Ark Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories6
Latest FDA decision2024-02-27
TypeNumberDevice NameCodeDateActions
510(k) K232522 ARK Levetiracetam II AssayORI2024-02-27 View
510(k) K232017 ARK Methotrexate II AssayLAO2023-12-20 View
510(k) K231752 ARK Hydrocodone AssayDJG2023-11-09 View
510(k) K201089 ARK Lacosamide AssayNWM2021-08-05 View
510(k) K200197 ARK Fentanyl II AssayDJG2020-02-26 View
510(k) K182280 ARK Tramadol AssayDJG2018-12-10 View
510(k) K182779 ARK EDDP AssayDJR2018-11-21 View
510(k) K180427 ARK Fentanyl AssayDJG2018-06-06 View
510(k) K163359 ARK Methotrexate AssayLAO2017-08-18 View
510(k) K153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite ControlPOX2016-08-09 View
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