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

    CONTROL DIAGNOSTICS PLATELET CONTROL

    K Number: K821851 · Decision Sep 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    71

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    Basic Information

    Device Name
    CONTROL DIAGNOSTICS PLATELET CONTROL
    K Number
    K821851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8175
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Immunogenetics
    Date Received
    June 23, 1982
    Decision Date
    September 2, 1982
    Product Code
    KRY
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRY Calibrator For Platelet Counting

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