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Ark Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories0
Latest FDA decision
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
510(k) K111904 ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANLAO2011-10-18 View
510(k) K101574 ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0OTF2010-11-23 View
510(k) K101305 ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLORH2010-10-29 View
510(k) K091884 ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003NWM2009-12-09 View
510(k) K091653 ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00ORI2009-11-02 View
510(k) K083799 TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00NWM2009-04-16 View
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