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

    A.QC HCT LEVEL 1 AND 2

    K Number: K893562 · Decision Jul 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    206
    Review Days
    66

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    Basic Information

    Device Name
    A.QC HCT LEVEL 1 AND 2
    K Number
    K893562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    May 9, 1989
    Decision Date
    July 14, 1989
    Product Code
    GLK
    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
    GLK Control, Hematocrit

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