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

    LASER-GLOBIN

    K Number: K850096 · Decision Mar 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    14
    Review Days
    77

    Basic Information

    Device Name
    LASER-GLOBIN
    K Number
    K850096
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    HEMATOLOGY MARKETING ASSOC.
    Date Received
    January 11, 1985
    Decision Date
    March 29, 1985
    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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    Other Clearances by HEMATOLOGY MARKETING ASSOC.

    K Number Device Name
    K851843 OSMOCEL 3
    K851375 TRI-COUNT
    K850094 LASER-GLOBIN POWDER
    K850095 LASER-DIL
    K850097 LASER-LYSE
    K844708 TRI-COUNT CALIBRATOR
    K843485 TRI-COUNT LASER
    K834371 TRI-COUNT 10
    K833130 TRI-COUNT 7
    K831306 HEMACAL
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