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

    STACLOT HEPARIN TEST KIT

    K Number: K943517 · Decision May 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    79
    Review Days
    294

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    Basic Information

    Device Name
    STACLOT HEPARIN TEST KIT
    K Number
    K943517
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Bioproducts Co.
    Date Received
    July 21, 1994
    Decision Date
    May 11, 1995
    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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