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

    HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME

    K Number: K860122 · Decision Apr 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    14
    Review Days
    80

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    Basic Information

    Device Name
    HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
    K Number
    K860122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Medical Device Consultants, Inc.
    Date Received
    January 14, 1986
    Decision Date
    April 4, 1986
    Product Code
    JBP
    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
    JBP Activated Whole Blood Clotting Time

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