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

    ANTI-RNP AND ANTI-SM ANTIBODY TEST

    K Number: K895338 · Decision Oct 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    55
    Review Days
    47

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    Basic Information

    Device Name
    ANTI-RNP AND ANTI-SM ANTIBODY TEST
    K Number
    K895338
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Immco Diagnostics, Inc.
    Date Received
    August 31, 1989
    Decision Date
    October 17, 1989
    Product Code
    LKO
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LKO Anti-Rnp Antibody, Antigen And Control

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