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

    VENTREZYME T4 IMMUNOASSAY T4

    K Number: K840473 · Decision Apr 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    8
    Review Days
    61

    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
    VENTREZYME T4 IMMUNOASSAY T4
    K Number
    K840473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Vxr, Inc.
    Date Received
    February 3, 1984
    Decision Date
    April 4, 1984
    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 Vxr, Inc.

    K Number Device Name
    K853703 VENTREZYME T3 IMMUNOASSAY T3
    K853748 VENTRESCREEN HCG URINE
    K841456 VENTREXYME EIA CONTROLS IMMUNOASSAY
    K833960 VENTREX PREGNANCY TEST KIT ENZYME
    K833989 VENTREZYME THEOPHYLLINE IMMUNOASSAY
    K833878 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
    K833909 VENTRESCREEN BETA-HCG ENZYME IMMUNO