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

    SYNCHRON CX 7 CLINICAL ANALYZER

    K Number: K904219 · Decision Oct 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    207
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    SYNCHRON CX 7 CLINICAL ANALYZER
    K Number
    K904219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Beckman
    Date Received
    September 12, 1990
    Decision Date
    October 22, 1990
    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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    Other Clearances by Beckman

    K Number Device Name
    K991707 MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
    K971534 SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROL
    K935362 P-AMYLASE CONTROL
    K904220 SYNCHRON CX4-CE
    K893583 BECKMAN CHOLINESTERASE REAGENT KIT