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

    125 I-T4 RIA TEST KIT

    K Number: K811070 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    120
    Applicant Total
    27
    Review Days
    9

    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
    125 I-T4 RIA TEST KIT
    K Number
    K811070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Intl. Immunoassay Laboratories, Inc.
    Date Received
    April 20, 1981
    Decision Date
    April 29, 1981
    Product Code
    CDX
    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
    CDX Radioimmunoassay, Total Thyroxine

    Similar 510(k) Clearances

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

    ELECSYS T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIVE THYROXINE RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DELFIA NEONATAL THYROXINE KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AXSYM(TM) TOTAL T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

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

    Other Clearances by Intl. Immunoassay Laboratories, Inc.

    K Number Device Name
    K913380 MYDAS(TM)-MB2/MYDAS(TM)-MB
    K913349 STAMBI-CK
    K912231 PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
    K903441 MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
    K903508 LABELLING CHANGES TO IMPRES-MB-X
    K901450 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
    K890609 IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
    K890543 IMPRES-MB REAGENT A AND REAGENT B
    K883432 IMMUNOCCULT-LXI
    K883222 ISOFOR-MM (TM)
    Search all 27 clearances from Intl. Immunoassay Laboratories, Inc. →