BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS

    K Number: K100589 · Decision Oct 29, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    319
    Review Days
    241

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    Basic Information

    Device Name
    MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
    K Number
    K100589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad
    Date Received
    March 2, 2010
    Decision Date
    October 29, 2010
    Product Code
    JSO
    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
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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