Ark Diagnostics, Inc.
Ark Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2024.
Top product codes for Ark Diagnostics, Inc.
Recent clearances by Ark Diagnostics, Inc.
- K232522 — ARK Levetiracetam II Assay
- K232017 — ARK Methotrexate II Assay
- K231752 — ARK Hydrocodone Assay
- K201089 — ARK Lacosamide Assay
- K200197 — ARK Fentanyl II Assay
- K182280 — ARK Tramadol Assay
- K182779 — ARK EDDP Assay
- K180427 — ARK Fentanyl Assay
- K163359 — ARK Methotrexate Assay
- DEN160033 — ARK Voriconazole II Assay Test System
- K153596 — ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
- K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
- K101574 — ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
- K101305 — ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
- K091884 — ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
- K091653 — ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
- K083799 — TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
Data sourced from openFDA. This site is unofficial and independent of the FDA.