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

    HELENA HEMOGLOBIN DETECT COLUMN SYS

    K Number: K820573 · Decision Apr 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    280
    Review Days
    30

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    Basic Information

    Device Name
    HELENA HEMOGLOBIN DETECT COLUMN SYS
    K Number
    K820573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    March 2, 1982
    Decision Date
    April 1, 1982
    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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