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

    CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

    K Number: K900685 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    10
    Review Days
    63

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    Basic Information

    Device Name
    CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
    K Number
    K900685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Texas Intl. Laboratories, Inc.
    Date Received
    February 12, 1990
    Decision Date
    April 16, 1990
    Product Code
    KQG
    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
    KQG Instrument, Coagulation

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