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

    ELECSYS CORTISOL TEST SYSTEM

    K Number: K070788 · Decision Oct 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    183
    Review Days
    197

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    Basic Information

    Device Name
    ELECSYS CORTISOL TEST SYSTEM
    K Number
    K070788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics
    Date Received
    March 22, 2007
    Decision Date
    October 5, 2007
    Product Code
    NHG
    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
    NHG Enzyme Immunoassay, Cortisol, Salivary

    Similar 510(k) Clearances

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    PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

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    ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

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    ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

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    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY

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    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
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