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

    CELL-MATICS HERPES SIMPLEX VIRUS DETECT

    K Number: K840366 · Decision Jan 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    121
    Review Days
    347

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    Basic Information

    Device Name
    CELL-MATICS HERPES SIMPLEX VIRUS DETECT
    K Number
    K840366
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.2280
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Difco Laboratories, Inc.
    Date Received
    January 27, 1984
    Decision Date
    January 8, 1985
    Product Code
    KIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    MI
    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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