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

    BITEK(TM) BLOOD CULTURE SYSTEM

    K Number: K875259 · Decision Jan 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    208
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    BITEK(TM) BLOOD CULTURE SYSTEM
    K Number
    K875259
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2300
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Definitive Diagnostics, Inc.
    Date Received
    December 22, 1987
    Decision Date
    January 27, 1988
    Product Code
    JSG
    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
    JSG Culture Media, Non-Selective And Non-Differential

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    Other Clearances by Definitive Diagnostics, Inc.

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