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

    BIOTRACK APTT CONTROLS

    K Number: K890051 · Decision Feb 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    16
    Review Days
    48

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    Basic Information

    Device Name
    BIOTRACK APTT CONTROLS
    K Number
    K890051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Biotrack, Inc.
    Date Received
    January 6, 1989
    Decision Date
    February 23, 1989
    Product Code
    GIT
    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
    GIT Reagent & Control, Partial Thromboplastin Time

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