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

    ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER

    K Number: K864849 · Decision Aug 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    1
    Review Days
    261

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    Basic Information

    Device Name
    ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
    K Number
    K864849
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Antek Instruments, Inc.
    Date Received
    December 10, 1986
    Decision Date
    August 28, 1987
    Product Code
    JJE
    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
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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