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

    COATEST(R) APC(TM) RESISTANCE

    K Number: K945940 · Decision Aug 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    245

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    Basic Information

    Device Name
    COATEST(R) APC(TM) RESISTANCE
    K Number
    K945940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Axis-Shield Doc AS
    Date Received
    December 5, 1994
    Decision Date
    August 7, 1995
    Product Code
    GGW
    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
    GGW Test, Time, Partial Thromboplastin

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