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

    BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

    K Number: K952751 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    8
    Review Days
    158

    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
    BIOCIRCUITS IOS T4/TU TEST CARTRIDGES
    K Number
    K952751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biocircuits Corp.
    Date Received
    June 15, 1995
    Decision Date
    November 20, 1995
    Product Code
    KLI
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

    Similar 510(k) Clearances

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

    VITROS® Automation Solutions

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GSP NEONATAL THYROXINE (T4)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS TOTAL T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Biocircuits Corp.

    K Number Device Name
    K981634 BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS
    K980819 BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS
    K963770 BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS
    K961566 BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS
    K961792 BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
    K952719 BIOCIRCUITS IOS (IN-OFFICE SYSTEM)
    K953837 BIOCIRCUITS IOS T4 TEST CARTRIDGE