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

    EASYTOUCH HEMOGLOBIN REAGENT

    K Number: K832750 · Decision Sep 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    19
    Review Days
    42

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    Basic Information

    Device Name
    EASYTOUCH HEMOGLOBIN REAGENT
    K Number
    K832750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Worthington Diagnostic Systems
    Date Received
    August 15, 1983
    Decision Date
    September 26, 1983
    Product Code
    KHG
    Advisory Committee
    Hematology
    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
    KHG Whole Blood Hemoglobin Determination

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    Other Clearances by Worthington Diagnostic Systems

    K Number Device Name
    K833708 COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
    K832748 COMPUR* EASYTOUCH TOTAL BILIRUBIN
    K832427 EASYTOUCH TROMBOPLASTIN REAGENT
    K832785 COMPUR* EASY TOUCH URIC ACID REAGENT
    K832749 EASYTOUCH BUN REAGENT SET
    K832426 EASYTOUCH TRIGLYCERIDES REAGENT SET
    K831477 DEMAND ANALYZER SYSTEM
    K831318 COMPUR* M1100 HEMATRCRIT SYSTEM
    K831227 COMPUR EASY TOUCH CHEMISTRY ANALYZER-
    K831102 TIA-IGA REAGENT & CALIBRATOR SETS
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