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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

    K Number: K070810 · Decision Jun 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    23
    Review Days
    74

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    Basic Information

    Device Name
    ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
    K Number
    K070810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biokit, S.A.
    Date Received
    March 26, 2007
    Decision Date
    June 8, 2007
    Product Code
    LGS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGS Fluorescence Polarization Immunoassay, Theophylline

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