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

    CI-TROL HEPARIN CONTROLS, LOW/HIGH

    K Number: K812424 · Decision Oct 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    149
    Review Days
    39

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    Basic Information

    Device Name
    CI-TROL HEPARIN CONTROLS, LOW/HIGH
    K Number
    K812424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    August 24, 1981
    Decision Date
    October 2, 1981
    Product Code
    KFF
    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
    KFF Assay, Heparin

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