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

    HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

    K Number: K053253 · Decision Feb 17, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
    K Number
    K053253
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2900
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemocue AB
    Date Received
    November 21, 2005
    Decision Date
    February 17, 2006
    Product Code
    KQO
    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
    KQO Automated Urinalysis System

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    Other Clearances by Hemocue AB

    K Number Device Name
    K201217 HemoCue Hb 301 System
    K181751 HemoCue Hb 801 System
    K071652 HEMOCUE WBC SYSTEM
    K060765 HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712
    K061047 HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801