BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ULTRACLONE ECL-01-1100

    K Number: K843579 · Decision Oct 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    21
    Review Days
    50

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    Basic Information

    Device Name
    ULTRACLONE ECL-01-1100
    K Number
    K843579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Earl-Clay Laboratories, Inc.
    Date Received
    September 11, 1984
    Decision Date
    October 31, 1984
    Product Code
    KIR
    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
    KIR Cells, Animal And Human, Cultured

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