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

    COMPUR* M1100 HEMATRCRIT SYSTEM

    K Number: K831318 · Decision Jun 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    14
    Applicant Total
    19
    Review Days
    47

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    Basic Information

    Device Name
    COMPUR* M1100 HEMATRCRIT SYSTEM
    K Number
    K831318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Worthington Diagnostic Systems
    Date Received
    April 22, 1983
    Decision Date
    June 8, 1983
    Product Code
    JPI
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JPI Device, Hematocrit Measuring

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    Other Clearances by Worthington Diagnostic Systems

    K Number Device Name
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    K832785 COMPUR* EASY TOUCH URIC ACID REAGENT
    K832749 EASYTOUCH BUN REAGENT SET
    K832750 EASYTOUCH HEMOGLOBIN REAGENT
    K832426 EASYTOUCH TRIGLYCERIDES REAGENT SET
    K831477 DEMAND ANALYZER SYSTEM
    K831227 COMPUR EASY TOUCH CHEMISTRY ANALYZER-
    K831102 TIA-IGA REAGENT & CALIBRATOR SETS
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