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

    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay

    K Number: K211648 · Decision Sep 8, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    61
    Applicant Total
    6
    Review Days
    468

    Basic Information

    Device Name
    Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
    K Number
    K211648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diazyme Laboratories Inc.
    Date Received
    May 28, 2021
    Decision Date
    September 8, 2022
    Product Code
    DFH
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DFH Kappa, Antigen, Antiserum, Control

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