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

    DIACROM *PLG

    K Number: K832591 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    28
    Review Days
    111

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    Basic Information

    Device Name
    DIACROM *PLG
    K Number
    K832591
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5715
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Wellcome Diagnostics
    Date Received
    August 2, 1983
    Decision Date
    November 21, 1983
    Product Code
    DDX
    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
    DDX Plasminogen, Antigen, Antiserum, Control

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