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

    HISTONES EIA DIAGNOSTIC KIT

    K Number: K870458 · Decision Mar 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    7
    Review Days
    55

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    Basic Information

    Device Name
    HISTONES EIA DIAGNOSTIC KIT
    K Number
    K870458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Biohytech International, Inc.
    Date Received
    January 21, 1987
    Decision Date
    March 17, 1987
    Product Code
    DHN
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by Biohytech International, Inc.

    K Number Device Name
    K870453 DS-DNA EIA DIAGNOSTIC KIT
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    K870452 SS-DNA EIA DIAGNOSTIC KIT
    K870456 DNP EIA DIAGNOSTIC KIT
    K862969 ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT