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Ark Diagnostics, Inc.

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ARK Levetiracetam II Assay (K232522)Ark Diagnostics, Inc.2024-02-27
ARK Methotrexate II Assay (K232017)Ark Diagnostics, Inc.2023-12-20
ARK Hydrocodone Assay (K231752)Ark Diagnostics, Inc.2023-11-09
ARK Lacosamide Assay (K201089)Ark Diagnostics, Inc.2021-08-05
ARK Fentanyl II Assay (K200197)Ark Diagnostics, Inc.2020-02-26
ARK Tramadol Assay (K182280)Ark Diagnostics, Inc.2018-12-10
ARK EDDP Assay (K182779)Ark Diagnostics, Inc.2018-11-21
ARK Fentanyl Assay (K180427)Ark Diagnostics, Inc.2018-06-06
ARK Methotrexate Assay (K163359)Ark Diagnostics, Inc.2017-08-18
ARK Voriconazole II Assay Test System (DEN160033)Ark Diagnostics, Inc.2017-05-05
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (K153596)Ark Diagnostics, Inc.2016-08-09
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN (K111904)Ark Diagnostics, Inc.2011-10-18
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 (K101574)Ark Diagnostics, Inc.2010-11-23
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (K101305)Ark Diagnostics, Inc.2010-10-29
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 (K091884)Ark Diagnostics, Inc.2009-12-09
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 (K091653)Ark Diagnostics, Inc.2009-11-02
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 (K083799)Ark Diagnostics, Inc.2009-04-16

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Every clearance here is in the API, with alerts when new ones post.