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

    MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES

    K Number: K854615 · Decision Jan 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    25
    Review Days
    71

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    Basic Information

    Device Name
    MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
    K Number
    K854615
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Serono Diagnostics, Inc.
    Date Received
    November 18, 1985
    Decision Date
    January 28, 1986
    Product Code
    LKI
    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
    LKI Antisera, Fluorescent, Chlamydia Spp.

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