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

    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

    K Number: K234091 · Decision Jul 22, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    241
    Applicant Total
    2
    Review Days
    209

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    Basic Information

    Device Name
    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
    K Number
    K234091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1690
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genalyte, Inc.
    Date Received
    December 26, 2023
    Decision Date
    July 22, 2024
    Product Code
    JLW
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JLW Radioimmunoassay, Thyroid-Stimulating Hormone

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    Other Clearances by Genalyte, Inc.

    K Number Device Name
    K191085 Maverick RNP Assay and Maverick Diagnostic System