FDA Product Code CDX: Radioimmunoassay, Total Thyroxine
Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Bio-Rad.
121
Total
121
Cleared
50d
Avg days
1976
Since
FDA 510(k) Cleared Radioimmunoassay, Total Thyroxine Devices (Product Code CDX)
121 devices
Cleared
Jun 13, 1996
ELECSYS T4 ASSAY
Boehringer Mannheim Corp.
Chemistry
56d
Cleared
Oct 07, 1995
ACTIVE THYROXINE RIA
Diagnostic Systems Laboratories, Inc.
Chemistry
22d
Cleared
Mar 10, 1995
DELFIA NEONATAL THYROXINE KIT
Wallac OY
Chemistry
238d
Cleared
Jun 21, 1994
AXSYM(TM) TOTAL T4
Abbott Laboratories
Chemistry
293d
Cleared
Oct 18, 1993
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
Sigma Diagnostics, Inc.
Chemistry
123d
Cleared
Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
Baxter Diagnostics, Inc.
Chemistry
44d
Cleared
Jan 26, 1993
ABBOTT IMX T4
Abbott Laboratories
Chemistry
109d
Cleared
Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
Abbott Laboratories
Chemistry
87d
Cleared
Oct 14, 1992
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
Heraeus Kulzer, Inc.
Chemistry
118d
Cleared
Jul 07, 1992
THYROXINE (T4) COATED TUBE RIA
Monobind
Chemistry
74d
Cleared
Apr 17, 1992
T4 EIA BEAD ASSAY
Tech-Co, Inc.
Chemistry
58d
Cleared
Jan 28, 1992
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT
Incstar Corp.
Chemistry
67d
Cleared
Aug 12, 1991
MILENIA TOTAL T4, CATALOG: MKT41,5
Diagnostic Products Corp.
Chemistry
63d
Cleared
Jan 17, 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology
85d
Cleared
Jan 15, 1991
CIBA CORNING ACS T4 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
Chemistry
36d
Cleared
Jul 27, 1990
MICROZYME T4 ENZYME IMMUNOASSAY KIT
Immunotech Corp.
Chemistry
24d
Cleared
Jun 20, 1990
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
Baxter Healthcare Corp
Chemistry
85d
Cleared
May 31, 1990
NEOCOAT T4
Neometrics, Inc.
Chemistry
31d
Cleared
Oct 04, 1989
TECHNICON RA SYSTEM THYROXINE T4 METHOD
Technicon Instruments Corp.
Chemistry
75d
Cleared
Dec 14, 1988
DELFIA THYROXINE (T4) KIT
Pharmacia, Inc.
Chemistry
117d
Cleared
Feb 16, 1988
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
Cyberfluor, Inc.
Chemistry
98d
Cleared
Feb 11, 1988
IMMPULSE T4 ASSAY REAGENTS
Sclavo, Inc.
Toxicology
64d
Cleared
Jul 21, 1987
CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
Chemistry
35d
Cleared
Jun 17, 1987
DELFIA(TM) THYROXINE (T4) KIT
Lkb Instruments, Inc.
Chemistry
77d