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

    N/T PROTEIN CONTROL PY

    K Number: K951012 · Decision Apr 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    145
    Review Days
    42

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    Basic Information

    Device Name
    N/T PROTEIN CONTROL PY
    K Number
    K951012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Behring Diagnostics, Inc.
    Date Received
    March 6, 1995
    Decision Date
    April 17, 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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