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

    BI-RA SLIDE TEST

    K Number: K811375 · Decision Jun 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    143
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    BI-RA SLIDE TEST
    K Number
    K811375
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5775
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biologics Intl., Inc.
    Date Received
    May 15, 1981
    Decision Date
    June 12, 1981
    Product Code
    DHR
    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
    DHR System, Test, Rheumatoid Factor

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    Other Clearances by Biologics Intl., Inc.

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    K811374 BI-CRP LATEX TEST
    K800605 ANA LATEX SLIDE TEST
    K791609 BE-SURE
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