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

    FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3

    K Number: K946265 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    17
    Review Days
    244

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    Basic Information

    Device Name
    FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
    K Number
    K946265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Clinical Controls, Inc.
    Date Received
    December 23, 1994
    Decision Date
    August 24, 1995
    Product Code
    GIL
    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
    GIL Plasma, Fibrinogen Control

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