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

    ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT

    K Number: K941001 · Decision Aug 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    182

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    Basic Information

    Device Name
    ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
    K Number
    K941001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Specialties
    Date Received
    March 1, 1994
    Decision Date
    August 30, 1994
    Product Code
    GIS
    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
    GIS Test, Fibrinogen

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