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Data / Medical devices / United States / Ark Diagnostics Inc

Ark Diagnostics Inc: FDA-registered device maker in Fremont, CA, United States, 15 510(k) clearances

Ark Diagnostics Inc is registered with the FDA (registration 3005755244) in Fremont, CA, United States. It lists 21 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 27, 2024. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Ark Diagnostics Inc
FDA registration number
3005755244
Address
48089 Fremont Blvd, Fremont, CA, United States, 94538
Owner or operator
ARK Diagnostics Inc (10027663)
Roles
Manufacturer, Manufacturer for export
First device listed
April 30, 2009
Registered through
2027
Brand names listed
ARK Apixaban Assay, ARK Apixaban Calibrator, ARK Apixaban Control, ARK Efavirenz Assay, ARK Efavirenz Calibrator, ARK Efavirenz Control, ARK Fentanyl 0.5 ng/mL Assay/Calibrator/Control, ARK Fentanyl II 0.5 ng/mL Assay and more

Devices it lists

DeviceProduct codeClassRoleSource
Anti-Factor Xa Activity Test System, ApixabanQLU2Manufacturer for exportaccessdata.fda.gov
Calibrators, Drug SpecificDLJ2Manufactureraccessdata.fda.gov
Drug Specific Control MaterialsLAS1Manufactureraccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, GentamicinLCD2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, MethotrexateLAOUManufactureraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, Oxcarbazepine MetabolitePOX2Manufactureraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufacturer for exportaccessdata.fda.gov
Gabapentin AssayOTF2Manufactureraccessdata.fda.gov
Immunoassay, Anti-Seizure DrugNWM2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Lamotrigine AssayORH2Manufactureraccessdata.fda.gov
Levetiracetam AssayORI2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Radioimmunoassay, VancomycinLEH2Manufacturer for exportaccessdata.fda.gov
Test Reagents For Ethyl AlcoholDMJ2Manufacturer for exportaccessdata.fda.gov
Test, Benzodiazepine, Employment And Insurance Testing, ExemptPUZ2Manufacturer for exportaccessdata.fda.gov
Test, Opiates, Employment And Insurance Testing, ExemptPVH2Manufactureraccessdata.fda.gov
Voriconazole Test SystemPUJ2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 27, 2024K232522ARK Levetiracetam II AssayORISubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
December 20, 2023K232017ARK Methotrexate II AssayLAOSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
November 9, 2023K231752ARK Hydrocodone AssayDJGSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
August 5, 2021K201089ARK Lacosamide AssayNWMSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
February 26, 2020K200197ARK Fentanyl II AssayDJGSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
December 10, 2018K182280ARK Tramadol AssayDJGSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
November 21, 2018K182779ARK EDDP AssayDJRSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
May 5, 2017DEN160033ARK Voriconazole II Assay Test SystemPUJUnknownArk Diagnostics, Inc.accessdata.fda.gov
August 9, 2016K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite ControlPOXSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
October 18, 2011K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANLAOSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
November 23, 2010K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0OTFSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
October 29, 2010K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLORHSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
December 9, 2009K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003NWMSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
November 2, 2009K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00ORISubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov
April 16, 2009K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00NWMSubstantially EquivalentArk Diagnostics, Inc.accessdata.fda.gov

Compare with other makers

Updated February 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.