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

    PLATELIA TOXO IGG KIT

    K Number: K894947 · Decision Mar 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    58
    Review Days
    232

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    Basic Information

    Device Name
    PLATELIA TOXO IGG KIT
    K Number
    K894947
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.7675
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Kallestad Diag, A Div. of Erbamont, Inc.
    Date Received
    August 3, 1989
    Decision Date
    March 23, 1990
    Product Code
    LGO
    Advisory Committee
    Hematology
    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
    LGO Test, Leukocyte Typing

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