BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

    K Number: K870945 · Decision Jun 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    93
    Review Days
    93

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    Basic Information

    Device Name
    RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
    K Number
    K870945
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2160
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Oxoid U.S.A., Inc.
    Date Received
    March 9, 1987
    Decision Date
    June 10, 1987
    Product Code
    JTL
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTL Plasma, Coagulase, Human, Horse And Rabbit

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