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

    CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS

    K Number: K860293 · Decision Feb 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    169
    Applicant Total
    121
    Review Days
    8

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    Basic Information

    Device Name
    CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
    K Number
    K860293
    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 28, 1986
    Decision Date
    February 5, 1986
    Product Code
    KIR
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    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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