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

    Tina-quant Lipoprotein(a) Gen.2 Molarity

    K Number: K241220 · Decision Jan 24, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    42
    Applicant Total
    5
    Review Days
    268

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    Basic Information

    Device Name
    Tina-quant Lipoprotein(a) Gen.2 Molarity
    K Number
    K241220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations
    Date Received
    May 1, 2024
    Decision Date
    January 24, 2025
    Product Code
    DFC
    Advisory Committee
    Immunology
    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
    DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control

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