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

    GASTRO-INTESTINAL ACCU-CULSHURE TM

    K Number: K903638 · Decision Jan 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    62
    Applicant Total
    17
    Review Days
    158

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    Basic Information

    Device Name
    GASTRO-INTESTINAL ACCU-CULSHURE TM
    K Number
    K903638
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Laboratory Automation Systems, Inc.
    Date Received
    August 13, 1990
    Decision Date
    January 18, 1991
    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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