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

    COATEST(R) ANTITHROMBIN III, MODIFICATION

    K Number: K931420 · Decision May 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    419

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    Basic Information

    Device Name
    COATEST(R) ANTITHROMBIN III, MODIFICATION
    K Number
    K931420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kabi Pharmacia Hepar, Inc.
    Date Received
    March 9, 1993
    Decision Date
    May 2, 1994
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

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