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

    ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)

    K Number: K060027 · Decision Jan 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    492
    Applicant Total
    23
    Review Days
    22

    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
    ARCHITECT DHEA-S CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM AND HIGH)
    K Number
    K060027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biokit, S.A.
    Date Received
    January 4, 2006
    Decision Date
    January 26, 2006
    Product Code
    JJX
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    Similar 510(k) Clearances

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

    Beta-CrossLaps CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Elecsys CYFRA 21-1 CalCheck 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Multichem A1c

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity DROP LQ Blood Glucose

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON CMV IgM Serum Control Set

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIAISON EBV IgM Serum Control Set

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

    Other Clearances by Biokit, S.A.

    K Number Device Name
    K243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
    K233606 ADVIA Centaur EBV-VCA IgM
    K233605 ADVIA Centaur EBV-EBNA IgG
    K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
    K214068 Quantia IgE
    K181334 ADVIA Centaur Herpes-2 IgG
    K181333 ADVIA Centaur Herpes-1 IgG
    K152185 ARCHITECT SHBG
    K132400 LP(A) CALIBRATORS, AND LP(A) CONTROLS
    K123947 ARCHITECT IVANCOMYCIN
    Search all 23 clearances from Biokit, S.A. →