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

    VARIOUS REAGENTS FOR BLOOD CELL ANALYZER

    K Number: K800180 · Decision Mar 19, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    8
    Review Days
    50

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    Basic Information

    Device Name
    VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
    K Number
    K800180
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Products, Inc.
    Date Received
    January 29, 1980
    Decision Date
    March 19, 1980
    Product Code
    GIF
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GIF Diluent, Blood Cell

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