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

    CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3

    K Number: K992829 · Decision Nov 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    107
    Review Days
    91

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    Basic Information

    Device Name
    CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
    K Number
    K992829
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    August 23, 1999
    Decision Date
    November 22, 1999
    Product Code
    GGN
    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
    GGN Plasma, Coagulation Control

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