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

    ATAC 2000 CHEMISTRY ANALYZER

    K Number: K851321 · Decision Apr 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    77
    Applicant Total
    6
    Review Days
    23

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    Basic Information

    Device Name
    ATAC 2000 CHEMISTRY ANALYZER
    K Number
    K851321
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Turpen Laboratory Systems, Inc.
    Date Received
    April 2, 1985
    Decision Date
    April 25, 1985
    Product Code
    JQP
    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
    JQP Calculator/Data Processing Module, For Clinical Use

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