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

    IP SPECIFIC G

    K Number: K830005 · Decision Jun 2, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    150

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    Basic Information

    Device Name
    IP SPECIFIC G
    K Number
    K830005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Reagent Tech.
    Date Received
    January 3, 1983
    Decision Date
    June 2, 1983
    Product Code
    DAA
    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
    DAA Igg, Peroxidase, Antigen, Antiserum, Control

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