BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇪🇸 Spain

    ARCHITECT SHBG

    K Number: K152185 · Decision Feb 11, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    88
    Applicant Total
    23
    Review Days
    190

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    Basic Information

    Device Name
    ARCHITECT SHBG
    K Number
    K152185
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1680
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biokit, S.A.
    Date Received
    August 5, 2015
    Decision Date
    February 11, 2016
    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

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    Other Clearances by Biokit, S.A.

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    K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
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    K181334 ADVIA Centaur Herpes-2 IgG
    K181333 ADVIA Centaur Herpes-1 IgG
    K132400 LP(A) CALIBRATORS, AND LP(A) CONTROLS
    K123947 ARCHITECT IVANCOMYCIN
    K110619 ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
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