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

    V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control

    K Number: K192931 · Decision Apr 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    915

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    Basic Information

    Device Name
    V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
    K Number
    K192931
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helena Laboratories, Corp.
    Date Received
    October 17, 2019
    Decision Date
    April 19, 2022
    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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