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

    ELX800UV

    K Number: K953572 · Decision Oct 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    257
    Applicant Total
    37
    Review Days
    80

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    Basic Information

    Device Name
    ELX800UV
    K Number
    K953572
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    July 31, 1995
    Decision Date
    October 19, 1995
    Product Code
    JJQ
    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
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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