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

    DUAL LAB-LITE LIGHT BOX

    K Number: K771486 · Decision Aug 22, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    DUAL LAB-LITE LIGHT BOX
    K Number
    K771486
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2270
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Technilab
    Date Received
    August 1, 1977
    Decision Date
    August 22, 1977
    Product Code
    DJS
    Advisory Committee
    Clinical Chemistry
    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
    DJS U.V. Light, Tlc