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

    SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)

    K Number: K914886 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    83
    Applicant Total
    23
    Review Days
    124

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    Basic Information

    Device Name
    SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
    K Number
    K914886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Serono-Baker Diagnostics, Inc.
    Date Received
    October 30, 1991
    Decision Date
    March 2, 1992
    Product Code
    CGR
    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
    CGR Radioimmunoassay, Cortisol

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