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

    SICKLE-2000

    K Number: K955719 · Decision Aug 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    240

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    Basic Information

    Device Name
    SICKLE-2000
    K Number
    K955719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicus Technologies, Inc.
    Date Received
    December 18, 1995
    Decision Date
    August 14, 1996
    Product Code
    GIQ
    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
    GIQ Hemoglobin S

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