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

    ACCU-CULSHURE TM

    K Number: K882637 · Decision Jul 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    9

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    Basic Information

    Device Name
    ACCU-CULSHURE TM
    K Number
    K882637
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2900
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Accu-Med Corp.
    Date Received
    June 27, 1988
    Decision Date
    July 6, 1988
    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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