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

    ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

    K Number: K071255 · Decision Sep 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    126

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    Basic Information

    Device Name
    ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
    K Number
    K071255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7695
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hyphen Biomed
    Date Received
    May 4, 2007
    Decision Date
    September 7, 2007
    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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