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

    CELLMATICS SHLAMYDIA DETECTION SYSTEM

    K Number: K893669 · Decision Jun 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    121
    Review Days
    39

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    Basic Information

    Device Name
    CELLMATICS SHLAMYDIA DETECTION SYSTEM
    K Number
    K893669
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Difco Laboratories, Inc.
    Date Received
    May 15, 1989
    Decision Date
    June 23, 1989
    Product Code
    LKH
    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
    LKH Antisera, Immunoperoxidase, Chlamydia Spp.

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