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

    BIOTEST HEMOGLOBIN MEASURING SYSTEM

    K Number: K020710 · Decision Aug 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    162

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    Basic Information

    Device Name
    BIOTEST HEMOGLOBIN MEASURING SYSTEM
    K Number
    K020710
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biotest Medizintechnik GmbH
    Date Received
    March 5, 2002
    Decision Date
    August 14, 2002
    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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