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

    DIRIA-PROGK IMMUNOASSAY

    K Number: K832694 · Decision Jan 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    56
    Applicant Total
    20
    Review Days
    154

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    Basic Information

    Device Name
    DIRIA-PROGK IMMUNOASSAY
    K Number
    K832694
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1620
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sorin Biomedica, Fiat, USA, Inc.
    Date Received
    August 10, 1983
    Decision Date
    January 11, 1984
    Product Code
    JLS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JLS Radioimmunoassay, Progesterone

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