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

    COMBION SKIN TEST

    K Number: K830688 · Decision Mar 31, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    COMBION SKIN TEST
    K Number
    K830688
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3120
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Nicholas H. Maganias
    Date Received
    March 4, 1983
    Decision Date
    March 31, 1983
    Product Code
    LKH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    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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    Other Clearances by Nicholas H. Maganias

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