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

    THROMBIN-PREST REAGENT KIT

    K Number: K884384 · Decision Dec 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    19
    Applicant Total
    79
    Review Days
    71

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    Basic Information

    Device Name
    THROMBIN-PREST REAGENT KIT
    K Number
    K884384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    American Bioproducts Co.
    Date Received
    October 18, 1988
    Decision Date
    December 28, 1988
    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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