CEC · Class II · 21 CFR 862.1695

FDA Product Code CEC: Radioimmunoassay, Free Thyroxine

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

92
Total
92
Cleared
104d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Radioimmunoassay, Free Thyroxine Devices (Product Code CEC)

92 devices
1–24 of 92
Cleared Mar 06, 2024
Access Free T4
K240273
Beckman Coulter, Inc.
Chemistry · 35d
Cleared Apr 07, 2023
Elecsys FT4 IV
K220456
Roche Diagnostics
Chemistry · 414d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423
Shenzhen New Industries Biomedical Engineering Co., Ltd.
Chemistry · 28d
Cleared Sep 18, 2018
Elecsys FT4 III
K181233
Roche Diagnostics
Chemistry · 132d
Cleared Oct 27, 2017
Abbott Architect Free T4
K173122
Abbott Laboratories
Chemistry · 28d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379
Abbott Laboratories
Chemistry · 26d
Cleared Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K073604
Dade Behring, Inc.
Chemistry · 83d
Cleared Mar 03, 2006
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
K053531
Dade Behring, Inc.
Chemistry · 74d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T4
K983417
Abbott Laboratories
Chemistry · 52d
Cleared Jul 14, 1998
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K982250
Beckman Instruments, Inc.
Chemistry · 18d
Cleared Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
K971792
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jun 11, 1996
ELECSYS FT4 ASSAY
K961489
Boehringer Mannheim Corp.
Chemistry · 54d
Cleared Apr 21, 1995
COBAS CORE FREE T3 EIA
K942376
Roche Diagnostic Systems, Inc.
Chemistry · 338d
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544
Abbott Laboratories
Chemistry · 272d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Aug 16, 1993
IMMULITE FREE T4
K931704
Diagnostic Products Corp.
Chemistry · 132d
Cleared May 20, 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110
Bio-Rad
Chemistry · 78d
Cleared Apr 20, 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 153d
Cleared Nov 16, 1992
VISTA FREE THYROXINE ASSAY
K923572
Syva Co.
Chemistry · 122d
Cleared Oct 26, 1992
KODAK AMERLITE MAB FT3 ASSAY
K922713
Eastman Kodak Company
Chemistry · 143d
Cleared Mar 02, 1992
AMERLITE MAB FT4 ASSAY
K920247
Eastman Kodak Company
Chemistry · 41d
Cleared Oct 07, 1991
AFFINITY FREE T4 TEST SYSTEM
K912698
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 111d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384
Abbott Laboratories
Chemistry · 45d

About Product Code CEC - Regulatory Context

510(k) Submission Activity

92 total 510(k) submissions under product code CEC since 1977, with 92 receiving FDA clearance (average review time: 104 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.