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

    COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM

    K Number: K042970 · Decision Dec 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    40

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    Basic Information

    Device Name
    COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
    K Number
    K042970
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copan Diagnostics, Inc.
    Date Received
    October 28, 2004
    Decision Date
    December 7, 2004
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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    Other Clearances by Copan Diagnostics, Inc.

    K Number Device Name
    K061301 COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
    K001780 COPAN VIRAL TRANSYSTEM
    K993161 COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
    K946283 COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUM
    K946287 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
    K946286 COPAN VENTURI TRANSYSTEM CARY-BLAIR MEDIUM
    K946288 COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUM
    K946284 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
    K946285 COPAN VENTURI TRANSYSTEM STUARTS MEDIUM