BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARK Levetiracetam Control

    Reg #: 3005755244 · FEI: 3005755244 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARK DIAGNOSTICS INC
    Registration Number
    3005755244
    FEI Number
    3005755244
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    48089 Fremont Blvd
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091653

    Owner / Operator

    Firm Name
    ARK Diagnostics Inc
    Operator Number
    10027663
    Address
    48089 Fremont Blvd
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US

    Products

    Device Name Product Code
    Calibrators, Drug Specific DLJ
    Levetiracetam Assay ORI
    Drug Specific Control Materials LAS

    Proprietary Names

    ARK Levetiracetam Control ARK Levetiracetam Calibrator ARK Levetiracetam Assay

    Establishment Types

    Manufacture Medical Device