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

    BBL CAMPYSLIDE(TM) TEST

    K Number: K864027 · Decision Dec 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    11
    Applicant Total
    632
    Review Days
    57

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    Basic Information

    Device Name
    BBL CAMPYSLIDE(TM) TEST
    K Number
    K864027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3110
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    October 15, 1986
    Decision Date
    December 11, 1986
    Product Code
    LQP
    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
    LQP Campylobacter Spp.

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