ClearanceBrief
Company ยท US

Ark Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2024. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DJGEnzyme Immunoassay, Opiates4
LAOEnzyme Immunoassay, Methotrexate3
NWMImmunoassay, Anti-Seizure Drug3
ORILevetiracetam Assay2
DJREnzyme Immunoassay, Methadone1
ORHLamotrigine Assay1
OTFGabapentin Assay1
POXEnzyme Immunoassay, Oxcarbazepine Metabolite1
PUJVoriconazole Test System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 27, 2024K232522ARK Levetiracetam II Assay
Ark Diagnostics, Inc.
ORI
Dec 20, 2023K232017ARK Methotrexate II Assay
Ark Diagnostics, Inc.
LAO
Nov 9, 2023K231752ARK Hydrocodone Assay
Ark Diagnostics, Inc.
DJG
Aug 5, 2021K201089ARK Lacosamide Assay
Ark Diagnostics, Inc.
NWM
Feb 26, 2020K200197ARK Fentanyl II Assay
Ark Diagnostics, Inc.
DJG
Dec 10, 2018K182280ARK Tramadol Assay
Ark Diagnostics, Inc.
DJG
Nov 21, 2018K182779ARK EDDP Assay
Ark Diagnostics, Inc.
DJR
Jun 6, 2018K180427ARK Fentanyl Assay
Ark Diagnostics, Inc.
DJG
Aug 18, 2017K163359ARK Methotrexate Assay
Ark Diagnostics, Inc.
LAO
May 5, 2017DEN160033ARK Voriconazole II Assay Test System
Ark Diagnostics, Inc.
PUJ
Aug 9, 2016K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control
Ark Diagnostics, Inc.
POX
Oct 18, 2011K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
Ark Diagnostics, Inc.
LAO
Nov 23, 2010K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
Ark Diagnostics, Inc.
OTF
Oct 29, 2010K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
Ark Diagnostics, Inc.
ORH
Dec 9, 2009K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
Ark Diagnostics, Inc.
NWM
Nov 2, 2009K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
Ark Diagnostics, Inc.
ORI
Apr 16, 2009K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
Ark Diagnostics, Inc.
NWM

Latest recalls

DateFirm and productCodeLinked 510(k)
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