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

    DR.BRUNO LANGE MINI-HBA1 PHOTOMETER

    K Number: K865055 · Decision Mar 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
    K Number
    K865055
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Diversa Corp.
    Date Received
    December 24, 1986
    Decision Date
    March 19, 1987
    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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