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ARK Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232522ARK Levetiracetam II AssayFebruary 27, 2024
K232017ARK Methotrexate II AssayDecember 20, 2023
K231752ARK Hydrocodone AssayNovember 9, 2023
K201089ARK Lacosamide AssayAugust 5, 2021
K200197ARK Fentanyl II AssayFebruary 26, 2020
K182280ARK Tramadol AssayDecember 10, 2018
K182779ARK EDDP AssayNovember 21, 2018
K180427ARK Fentanyl AssayJune 6, 2018
K163359ARK Methotrexate AssayAugust 18, 2017
DEN160033ARK Voriconazole II Assay Test SystemMay 5, 2017
K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine MetabAugust 9, 2016
K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTOctober 18, 2011
K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-November 23, 2010
K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLOctober 29, 2010
K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 502December 9, 2009
K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-000November 2, 2009
K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0April 16, 2009