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

    GTI-PF4 ELISA

    K Number: K983379 · Decision Mar 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    165

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    Basic Information

    Device Name
    GTI-PF4 ELISA
    K Number
    K983379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7695
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genetic Testing Institute
    Date Received
    September 25, 1998
    Decision Date
    March 9, 1999
    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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