BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

    K Number: K974027 · Decision Feb 2, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    3
    Review Days
    102

    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
    AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
    K Number
    K974027
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Biotech (Uk) , Ltd.
    Date Received
    October 23, 1997
    Decision Date
    February 2, 1998
    Product Code
    CDP
    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
    CDP Radioimmunoassay, Total Triiodothyronine

    Similar 510(k) Clearances

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

    REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CHIRON DIAGNOSTICS ACS: 180 FT3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AIA-PACK FT3 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTICOAT T3 EIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ABBOTT ARCHITECT FREE T3

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

    Other Clearances by Alfa Biotech (Uk) , Ltd.

    K Number Device Name
    K980574 AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0
    K974505 AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501