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

    HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES

    K Number: K884590 · Decision Jan 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    15
    Review Days
    68

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    Basic Information

    Device Name
    HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
    K Number
    K884590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hemotec, Inc.
    Date Received
    November 3, 1988
    Decision Date
    January 10, 1989
    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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