BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    CHROMOTITRE E.I.A. RUBELLA IGG

    K Number: K872071 · Decision Aug 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    CHROMOTITRE E.I.A. RUBELLA IGG
    K Number
    K872071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ismunit Istituto Immunologico Intaliano
    Date Received
    May 29, 1987
    Decision Date
    August 24, 1987
    Product Code
    LFX
    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
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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    Other Clearances by Ismunit Istituto Immunologico Intaliano

    K Number Device Name
    K872070 CHROMOTITRE E.I.A. TOXOPLASMA IGM