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

    TANARAMA

    K Number: K812603 · Decision Nov 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    66

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    Basic Information

    Device Name
    TANARAMA
    K Number
    K812603
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Marketing Consultants of America
    Date Received
    September 15, 1981
    Decision Date
    November 20, 1981
    Product Code
    GGG
    Advisory Committee
    Hematology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGG Guaiac Reagent

    Other Clearances by Marketing Consultants of America

    K Number Device Name
    K812543 TANARAMA