BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT

    K Number: K881125 · Decision Mar 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    62
    Applicant Total
    58
    Review Days
    7

    Basic Information

    Device Name
    PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
    K Number
    K881125
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
    Date Received
    March 16, 1988
    Decision Date
    March 23, 1988
    Product Code
    LIO
    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
    LIO Device, Specimen Collection

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