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

    COATEST ANTIPLASMIN

    K Number: K833890 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    82

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    Basic Information

    Device Name
    COATEST ANTIPLASMIN
    K Number
    K833890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Kabivitrum, Inc.
    Date Received
    November 9, 1983
    Decision Date
    January 30, 1984
    Product Code
    LGP
    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
    LGP Assay, Alpha-2-Antiplasmin

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    K832114 COATEST FACTOR X
    K812829 COATEST ANTITHROMBIN