Ark Diagnostics Inc
Fremont, CA, US
ARK DIAGNOSTICS INC appears in FDA device records in Fremont, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Ark Diagnostics Inc between 2009 and 2024. The busiest year on record is 2009, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | ORI | Substantially Equivalent | |
| K232017 | ARK Methotrexate II Assay | LAO | Substantially Equivalent | |
| K231752 | ARK Hydrocodone Assay | DJG | Substantially Equivalent | |
| K201089 | ARK Lacosamide Assay | NWM | Substantially Equivalent | |
| K200197 | ARK Fentanyl II Assay | DJG | Substantially Equivalent | |
| K182280 | ARK Tramadol Assay | DJG | Substantially Equivalent | |
| K182779 | ARK EDDP Assay | DJR | Substantially Equivalent | |
| K180427 | ARK Fentanyl Assay | DJG | Substantially Equivalent | |
| K163359 | ARK Methotrexate Assay | LAO | Substantially Equivalent | |
| DEN160033 | ARK Voriconazole II Assay Test System | PUJ | Unknown | |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | POX | Substantially Equivalent | |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | LAO | Substantially Equivalent | |
| K101574 | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 | OTF | Substantially Equivalent | |
| K101305 | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL | ORH | Substantially Equivalent | |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 | NWM | Substantially Equivalent | |
| K091653 | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 | ORI | Substantially Equivalent | |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 | NWM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005755244 | 3005755244 | ARK DIAGNOSTICS INC | 48089 Fremont Blvd, Fremont, CA 94538 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DLJCalibrators, Drug Specific
- LASDrug Specific Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- LCDEnzyme Immunoassay, Gentamicin
- DJREnzyme Immunoassay, Methadone
- LAOEnzyme Immunoassay, Methotrexate
- DJGEnzyme Immunoassay, Opiates
- POXEnzyme Immunoassay, Oxcarbazepine Metabolite
- LCMEnzyme Immunoassay, Phencyclidine
- OTFGabapentin Assay
- NWMImmunoassay, Anti-Seizure Drug
- ORHLamotrigine Assay
- ORILevetiracetam Assay
- LEHRadioimmunoassay, Vancomycin
- DMJTest Reagents For Ethyl Alcohol
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
- PUJVoriconazole Test System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain