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

    DRG SLV TESTOSTERONE ELISA TEST

    K Number: K052649 · Decision Jan 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    4
    Review Days
    123

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    DRG SLV TESTOSTERONE ELISA TEST
    K Number
    K052649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drg Intl., Inc.
    Date Received
    September 26, 2005
    Decision Date
    January 27, 2006
    Product Code
    CDZ
    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
    CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CDZ), ordered by most recent decision date.

    IDS-iSYS Total Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IDS-iSYS Free Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Access SHBG

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Access Testosterone

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys Testosterone II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON Testosterone xt

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Drg Intl., Inc.

    K Number Device Name
    K062534 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
    K051733 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
    K000043 DRG AURICA ELISA TESTOSTERONE KIT