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

    IMMULITE (TM) TOTAL T3

    K Number: K905214 · Decision Feb 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    143
    Applicant Total
    10
    Review Days
    73

    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
    IMMULITE (TM) TOTAL T3
    K Number
    K905214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1710
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Cirrus Diagnostics, Inc.
    Date Received
    November 20, 1990
    Decision Date
    February 1, 1991
    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 Cirrus Diagnostics, Inc.

    K Number Device Name
    K921704 IMMULITE(R) FSH
    K920411 IMMULITE HLH
    K914833 IMMULITE DIGOXIN
    K911796 IMMULITE(TM) HCG
    K910677 IMMULITE(TM) T-UPTAKE
    K910261 IMMULITE(TM) TOTAL T4
    K905648 CRP LIPID REAGENT TEST PACK
    K905769 IMMULITE HS-TSH
    K905215 IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER