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

    ACS ONE-STAGE PROTHROMBIN TIME REAGENT

    K Number: K902468 · Decision Aug 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    42
    Review Days
    67

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    Basic Information

    Device Name
    ACS ONE-STAGE PROTHROMBIN TIME REAGENT
    K Number
    K902468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Analytical Control Systems, Inc.
    Date Received
    June 4, 1990
    Decision Date
    August 10, 1990
    Product Code
    GJS
    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
    GJS Test, Time, Prothrombin

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