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

    YEAST IDENTIFICATION PANEL

    K Number: K860575 · Decision May 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    15
    Applicant Total
    24
    Review Days
    84

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    Basic Information

    Device Name
    YEAST IDENTIFICATION PANEL
    K Number
    K860575
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    February 18, 1986
    Decision Date
    May 13, 1986
    Product Code
    JXB
    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
    JXB Kit, Identification, Yeast

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