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

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

    K Number: K011323 · Decision Dec 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    230

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    Basic Information

    Device Name
    HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
    K Number
    K011323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1205
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Salimetrics, LLC
    Date Received
    May 1, 2001
    Decision Date
    December 17, 2001
    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

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    Other Clearances by Salimetrics, LLC

    K Number Device Name
    K051012 PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
    K031348 HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY