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

    HEMATACHEK

    K Number: K964452 · Decision Feb 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    106

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    Basic Information

    Device Name
    HEMATACHEK
    K Number
    K964452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Richmond Diagnostics, Inc.
    Date Received
    November 6, 1996
    Decision Date
    February 20, 1997
    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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