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

    Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

    K Number: K171664 · Decision Sep 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    82
    Review Days
    100

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    Basic Information

    Device Name
    Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
    K Number
    K171664
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Rad Laboratories, Inc.
    Date Received
    June 5, 2017
    Decision Date
    September 13, 2017
    Product Code
    GKA
    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
    GKA Abnormal Hemoglobin Quantitation

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