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

    SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101

    K Number: K861460 · Decision May 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
    K Number
    K861460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3780
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Widran Urological Group, Ltd.
    Date Received
    April 18, 1986
    Decision Date
    May 2, 1986
    Product Code
    LJK
    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
    LJK Antisera, If, Toxoplasma Gondii

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    Other Clearances by Widran Urological Group, Ltd.

    K Number Device Name
    K822743 SOLID STATE CONTINUOUS FLOW CONTROL