BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    HemoCue Hb 301 System

    K Number: K201217 · Decision Aug 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    HemoCue Hb 301 System
    K Number
    K201217
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemocue AB
    Date Received
    May 6, 2020
    Decision Date
    August 4, 2020
    Product Code
    GKR
    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
    GKR System, Hemoglobin, Automated

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    Other Clearances by Hemocue AB

    K Number Device Name
    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
    K053253 HEMOCUE ALBUMIN 201 ANALYZING SYSTEM