BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

    K Number: K023991 · Decision Apr 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    146

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    Basic Information

    Device Name
    CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
    K Number
    K023991
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Biologic
    Date Received
    December 3, 2002
    Decision Date
    April 28, 2003
    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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