BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEMA(PRO)TEC(TION)

    K Number: K885324 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    21
    Applicant Total
    3
    Review Days
    51

    Basic Information

    Device Name
    HEMA(PRO)TEC(TION)
    K Number
    K885324
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6150
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    MEDICAL PRODUCTS SEARCH, INC.
    Date Received
    December 28, 1988
    Decision Date
    February 17, 1989
    Product Code
    GIO
    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
    GIO Tube, Collection, Capillary Blood

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