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

    HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls

    K Number: K153137 · Decision Jul 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    321
    Review Days
    252

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    Basic Information

    Device Name
    HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
    K Number
    K153137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7695
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    October 30, 2015
    Decision Date
    July 8, 2016
    Product Code
    LCO
    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
    LCO Platelet Factor 4 Radioimmunoassay

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