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

    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

    K Number: K972448 · Decision Aug 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    51

    Basic Information

    Device Name
    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
    K Number
    K972448
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COPAN ITALIA SPA
    Date Received
    June 30, 1997
    Decision Date
    August 20, 1997
    Product Code
    JSL
    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
    JSL Culture Media, Anaerobic Transport

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    Other Clearances by COPAN ITALIA SPA

    K Number Device Name
    K972449 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL