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

    MICRODILUTION IDENTIFICATION PANELS

    K Number: K864674 · Decision Jan 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    52
    Applicant Total
    24
    Review Days
    34

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    Basic Information

    Device Name
    MICRODILUTION IDENTIFICATION PANELS
    K Number
    K864674
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    December 2, 1986
    Decision Date
    January 5, 1987
    Product Code
    JSE
    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
    JSE Culture Media, Multiple Biochemical Test

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    Other Clearances by American Micro Scan

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    K863776 MICRODILUTION MIC PANELS
    K864389 CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
    K863038 GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
    K862642 GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
    K862332 ANAEROBE RAPID CHROMOGENIC ID PANEL
    K862140 MICRODILUTION PANELS
    K861584 GRAM NEGATIVE COMBO PANEL TYPE 3
    K860575 YEAST IDENTIFICATION PANEL
    Search all 24 clearances from American Micro Scan →