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

    ANAEROBIC ACCU-CULSHURE(TM)

    K Number: K901645 · Decision Jul 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    17
    Review Days
    98

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    Basic Information

    Device Name
    ANAEROBIC ACCU-CULSHURE(TM)
    K Number
    K901645
    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
    April 9, 1990
    Decision Date
    July 16, 1990
    Product Code
    JTX
    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
    JTX Transport Systems, Anaerobic

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