BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS

    K Number: K855091 · Decision Mar 14, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS
    K Number
    K855091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sen Tech Medical Corp.
    Date Received
    December 20, 1985
    Decision Date
    March 14, 1986
    Product Code
    CDS
    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
    CDS Electrode, Ion Specific, Urea Nitrogen

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