BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ARK Levetiracetam II Assay

    K Number: K232522 · Decision Feb 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    17
    Review Days
    193

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    Basic Information

    Device Name
    ARK Levetiracetam II Assay
    K Number
    K232522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3350
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ark Diagnostics, Inc.
    Date Received
    August 18, 2023
    Decision Date
    February 27, 2024
    Product Code
    ORI
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ORI Levetiracetam Assay

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ORI), ordered by most recent decision date.

    ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

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