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

    OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

    K Number: K894617 · Decision Oct 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    15
    Review Days
    103

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    Basic Information

    Device Name
    OLYMPUS PK-TP SYSTEM REACTIVE CONTROL
    K Number
    K894617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3135
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Schiff & Co.
    Date Received
    July 20, 1989
    Decision Date
    October 31, 1989
    Product Code
    GMI
    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
    GMI Antigen, Cf And / Or Id, Coccidioides Immitis

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