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

    N-ASSAY TIA ANTITHROMBIN III TEST KIT

    K Number: K972257 · Decision Oct 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    29
    Review Days
    125

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    Basic Information

    Device Name
    N-ASSAY TIA ANTITHROMBIN III TEST KIT
    K Number
    K972257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Crestat Diagnostics, Inc.
    Date Received
    June 17, 1997
    Decision Date
    October 20, 1997
    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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