BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    IDEIA(TM) CHLAMYDIA, MODIFICATION

    K Number: K911430 · Decision Aug 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    IDEIA(TM) CHLAMYDIA, MODIFICATION
    K Number
    K911430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Novo Nordisk Diagnostics, Ltd.
    Date Received
    March 28, 1991
    Decision Date
    August 7, 1991
    Product Code
    LIC
    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
    LIC Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae

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    Other Clearances by Novo Nordisk Diagnostics, Ltd.

    K Number Device Name
    K901972 ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA