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

    ROBOTIC SAMPLE PROCESSOR

    K Number: K894126 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    139
    Applicant Total
    6
    Review Days
    64

    Basic Information

    Device Name
    ROBOTIC SAMPLE PROCESSOR
    K Number
    K894126
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2750
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    TECAN U.S., LTD.
    Date Received
    June 12, 1989
    Decision Date
    August 15, 1989
    Product Code
    JQW
    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
    JQW Station, Pipetting And Diluting, For Clinical Use

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