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

    DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA

    K Number: K935307 · Decision Nov 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    72
    Review Days
    385

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    Basic Information

    Device Name
    DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
    K Number
    K935307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    November 2, 1993
    Decision Date
    November 22, 1994
    Product Code
    DDQ
    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
    DDQ Antigen, Antiserum, Control, Antithrombin Iii

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