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

    IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

    K Number: K970227 · Decision Apr 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
    K Number
    K970227
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dpc Cirrus
    Date Received
    January 17, 1997
    Decision Date
    April 8, 1997
    Product Code
    JJE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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    Other Clearances by Dpc Cirrus

    K Number Device Name
    K980855 IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT