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

    IL SYSTEM 810, ACL AND THE REAGENT SETS

    K Number: K862301 · Decision Sep 3, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    19
    Applicant Total
    321
    Review Days
    78

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    Basic Information

    Device Name
    IL SYSTEM 810, ACL AND THE REAGENT SETS
    K Number
    K862301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Instrumentation Laboratory CO
    Date Received
    June 17, 1986
    Decision Date
    September 3, 1986
    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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