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

    A-FACT, ABNORMAL FACTOR ASSAY CONTROL

    K Number: K945855 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    5
    Review Days
    344

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    Basic Information

    Device Name
    A-FACT, ABNORMAL FACTOR ASSAY CONTROL
    K Number
    K945855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    George King Bio-Medical, Inc.
    Date Received
    November 14, 1994
    Decision Date
    October 24, 1995
    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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