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

    KWI (TM) G-CO/TWO

    K Number: K855172 · Decision Feb 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    69
    Applicant Total
    9
    Review Days
    56

    Basic Information

    Device Name
    KWI (TM) G-CO/TWO
    K Number
    K855172
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    MICRO-BIO-LOGICS
    Date Received
    December 26, 1985
    Decision Date
    February 20, 1986
    Product Code
    JSK
    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
    JSK Supplement, Culture Media

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