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

    ORTHO HEMATOLOGY CONTROL ABNORMAL LOW

    K Number: K803084 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    191
    Applicant Total
    6
    Review Days
    26

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    Basic Information

    Device Name
    ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
    K Number
    K803084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Instruments
    Date Received
    December 5, 1980
    Decision Date
    December 31, 1980
    Product Code
    JPK
    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
    JPK Mixture, Hematology Quality Control

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