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

    MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)

    K Number: K150039 · Decision Jul 2, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    49
    Applicant Total
    152
    Review Days
    174

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    Basic Information

    Device Name
    MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
    K Number
    K150039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare Diagnostics, Inc.
    Date Received
    January 9, 2015
    Decision Date
    July 2, 2015
    Product Code
    LTT
    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
    LTT Panels, Test, Susceptibility, Antimicrobial

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