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

    MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST

    K Number: K870946 · Decision Apr 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    34
    Applicant Total
    25
    Review Days
    51

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    Basic Information

    Device Name
    MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
    K Number
    K870946
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Serono Diagnostics, Inc.
    Date Received
    March 9, 1987
    Decision Date
    April 29, 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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