BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT

    K Number: K982023 · Decision Sep 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    138
    Review Days
    87

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    Basic Information

    Device Name
    PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
    K Number
    K982023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5530
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inova Diagnostics, Inc.
    Date Received
    June 9, 1998
    Decision Date
    September 4, 1998
    Product Code
    DAS
    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
    DAS Igg (Fc Fragment Specific), Antigen, Antiserum, Control

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