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

    ANA LATEX SLIDE TEST

    K Number: K800605 · Decision Apr 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    16

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    Basic Information

    Device Name
    ANA LATEX SLIDE TEST
    K Number
    K800605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5820
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biologics Intl., Inc.
    Date Received
    March 17, 1980
    Decision Date
    April 2, 1980
    Product Code
    DHC
    Advisory Committee
    Immunology
    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
    DHC System, Test, Systemic Lupus Erythematosus

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