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

    SENSITITRE AUTO ID PLATE AP80

    K Number: K890057 · Decision Jun 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    50
    Review Days
    154

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    Basic Information

    Device Name
    SENSITITRE AUTO ID PLATE AP80
    K Number
    K890057
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Radiometer America, Inc.
    Date Received
    January 6, 1989
    Decision Date
    June 9, 1989
    Product Code
    LQM
    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
    LQM Gram Negative Identification Panel

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