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

    DSL BETA 2 MICROGLOBULIN (DSL 6200)

    K Number: K911881 · Decision Sep 10, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    52
    Applicant Total
    94
    Review Days
    134

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    Basic Information

    Device Name
    DSL BETA 2 MICROGLOBULIN (DSL 6200)
    K Number
    K911881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5630
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Systems Laboratories, Inc.
    Date Received
    April 29, 1991
    Decision Date
    September 10, 1991
    Product Code
    JZG
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JZG System, Test, Beta-2-Microglobulin Immunological

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