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

    ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589

    K Number: K982209 · Decision Oct 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    19
    Applicant Total
    164
    Review Days
    114

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    Basic Information

    Device Name
    ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
    K Number
    K982209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sigma Diagnostics, Inc.
    Date Received
    June 23, 1998
    Decision Date
    October 15, 1998
    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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