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

    ISOTONIC BLOOD CELL DILUENT J & S

    K Number: K833443 · Decision Nov 3, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    ISOTONIC BLOOD CELL DILUENT J & S
    K Number
    K833443
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.8200
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Jasins & Sayles Associates, Inc.
    Date Received
    October 5, 1983
    Decision Date
    November 3, 1983
    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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    Other Clearances by Jasins & Sayles Associates, Inc.

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