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

    HEPARIN CONTROL PLASMA

    K Number: K760918 · Decision Jan 10, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    51
    Applicant Total
    44
    Review Days
    74

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    Basic Information

    Device Name
    HEPARIN CONTROL PLASMA
    K Number
    K760918
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hyland Therapeutic Div., Travenol Laboratories
    Date Received
    October 28, 1976
    Decision Date
    January 10, 1977
    Product Code
    GFO
    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
    GFO Activated Partial Thromboplastin

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    K802610 ALERT A,HDL-APOLIPOROTEIN A, TEST KIT
    K791113 LOW IONIC STRENGTH SOLUTION (LISS)
    K790249 TEST CELLS
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    K780962 AUTOMATED ENZYME
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