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

    DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM

    K Number: K862320 · Decision Aug 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    34
    Applicant Total
    121
    Review Days
    62

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    Basic Information

    Device Name
    DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
    K Number
    K862320
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Difco Laboratories, Inc.
    Date Received
    June 18, 1986
    Decision Date
    August 19, 1986
    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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