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

    CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

    K Number: K864662 · Decision Mar 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    34
    Applicant Total
    24
    Review Days
    117

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    Basic Information

    Device Name
    CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
    K Number
    K864662
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    American Micro Scan
    Date Received
    November 28, 1986
    Decision Date
    March 25, 1987
    Product Code
    LJP
    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
    LJP Antiserum, Fluorescent, Chlamydia Trachomatis

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    Other Clearances by American Micro Scan

    K Number Device Name
    K870029 IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE
    K863776 MICRODILUTION MIC PANELS
    K864674 MICRODILUTION IDENTIFICATION 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 →