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

    AUTOMATED ELISA READER LBI 300

    K Number: K830227 · Decision Mar 10, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    45

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    Basic Information

    Device Name
    AUTOMATED ELISA READER LBI 300
    K Number
    K830227
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2540
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bionetic Laboratory Products
    Date Received
    January 24, 1983
    Decision Date
    March 10, 1983
    Product Code
    JTQ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTQ Bath, Incubators/Water, All

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