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

    DADE(R) PROTEIN C ABNORMAL CONTRAL

    K Number: K911885 · Decision Jun 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    39
    Applicant Total
    505
    Review Days
    43

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    Basic Information

    Device Name
    DADE(R) PROTEIN C ABNORMAL CONTRAL
    K Number
    K911885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    April 29, 1991
    Decision Date
    June 11, 1991
    Product Code
    GGC
    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
    GGC Control, Plasma, Abnormal

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