CDX · Class II · 21 CFR 862.1700

FDA Product Code CDX: Radioimmunoassay, Total Thyroxine

Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Diagnostic Products Corp..

121
Total
121
Cleared
50d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Total Thyroxine Devices (Product Code CDX)

121 devices
1–24 of 121
Cleared Jun 13, 1996
ELECSYS T4 ASSAY
K961490
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384
Abbott Laboratories
Chemistry · 293d
Cleared Jan 26, 1993
ABBOTT IMX T4
K925110
Abbott Laboratories
Chemistry · 109d
Cleared Jan 04, 1993
ABBOTT TDX/TDXFLX TT4
K925109
Abbott Laboratories
Chemistry · 87d
Cleared Aug 12, 1991
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541
Diagnostic Products Corp.
Chemistry · 63d
Cleared Jan 17, 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 85d
Cleared Jun 20, 1990
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475
Baxter Healthcare Corp
Chemistry · 85d
Cleared Dec 16, 1986
IQ T4 IMMUNOASSAY
K864560
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 27d
Cleared May 18, 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107
Diagnostic Products Corp.
Chemistry · 43d
Cleared Dec 09, 1982
MONOCLONAL ANTIBODY T4 RADIO-KIT
K823265
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 37d
Cleared Jul 10, 1981
QUANTAPHASE T-4 RIA
K811787
Bio-Rad
Chemistry · 17d
Cleared May 27, 1981
COAT-A-COUNT T4 RIA KIT
K811315
Diagnostic Products Corp.
Chemistry · 16d
Cleared Mar 19, 1980
RIA PHASE T4
K800203
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Nov 27, 1979
TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
K792188
Abbott Laboratories
Immunology · 27d
Cleared Jul 30, 1979
QUANTIMUNE T-4 FIA
K790576
Bio-Rad
Chemistry · 124d
Cleared Aug 14, 1978
MICRO THYROXINE REAGENT SYSTEM
K781182
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 31d
Cleared May 03, 1978
EMIT CENTRIFICHEM THYROXINE ASSAY
K780639
Syva Co.
Toxicology · 16d
Cleared Mar 17, 1978
REAGENTS, MANUEAL, ASSAY, THYROXINE
K780121
Syva Co.
Chemistry · 53d
Cleared Mar 03, 1978
ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY
K780219
Syva Co.
Chemistry · 21d
Cleared Jan 12, 1978
T4 RIA KIT
K772330
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 22d
Cleared Dec 22, 1977
EMIT CENTRIFICHEM THYROXINE ASSAY
K772170
Syva Co.
Immunology · 31d
Cleared Aug 03, 1977
RIA FOR TOTAL THYROXINE
K771309
Abbott Laboratories
Chemistry · 16d
Cleared Jul 14, 1977
QUANTIMUNE NEONATAL & THYROXINE RIA
K771135
Bio-Rad
Immunology · 21d
Cleared Jun 24, 1977
REAGENT SYSTEM, THYROXINE, ARIA
K770733
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 65d

About Product Code CDX - Regulatory Context