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

    OLYMPUS PK(TM) TP

    K Number: K893124 · Decision Nov 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    45
    Review Days
    206

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    Basic Information

    Device Name
    OLYMPUS PK(TM) TP
    K Number
    K893124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Fujirebio Diagnostics,Inc.
    Date Received
    April 25, 1989
    Decision Date
    November 17, 1989
    Product Code
    GMT
    Advisory Committee
    Microbiology
    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
    GMT Antigens, Ha, Treponema Pallidum

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