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

    HEPAQUANT

    K Number: K813011 · Decision Jan 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    70
    Review Days
    91

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    Basic Information

    Device Name
    HEPAQUANT
    K Number
    K813011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Streck Laboratories, Inc.
    Date Received
    October 27, 1981
    Decision Date
    January 26, 1982
    Product Code
    JOX
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOX Analyzer, Heparin, Automated

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