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

    PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM

    K Number: K882623 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    157
    Review Days
    14

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    Basic Information

    Device Name
    PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM
    K Number
    K882623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5320
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Technicon Instruments Corp.
    Date Received
    June 24, 1988
    Decision Date
    July 8, 1988
    Product Code
    JZH
    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
    JZH Factor B, Antigen, Antiserum, Control

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