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

    THROMBIN CLOT TIME TEST PROCEDURE

    K Number: K923220 · Decision Sep 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    19
    Applicant Total
    17
    Review Days
    90

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    Basic Information

    Device Name
    THROMBIN CLOT TIME TEST PROCEDURE
    K Number
    K923220
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Laboratory Automation Systems, Inc.
    Date Received
    July 1, 1992
    Decision Date
    September 29, 1992
    Product Code
    GJA
    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
    GJA Test, Thrombin Time

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