CEC · Class II · 21 CFR 862.1695

FDA Product Code CEC: Radioimmunoassay, Free Thyroxine

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Abbott Laboratories and Amersham 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 26, 2014
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART
K140842
Siemens Healthcare Diagnostics, Inc.
Chemistry · 238d
Cleared Nov 26, 2014
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT
K140859
Siemens Healthcare Diagnostics, Inc.
Chemistry · 237d
Cleared Jan 27, 2014
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET
K131244
Roche Diagnostics
Chemistry · 271d
Cleared Sep 13, 2013
ADVIA CENTAUR FT4, ADVIA CENTAUR T4
K132249
Siemens Healthcare Diagnostics, Inc.
Chemistry · 56d
Cleared Apr 04, 2013
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
K121951
DiaSorin, Inc.
Chemistry · 275d
Cleared Nov 27, 2012
ABBOTT ARCHITECT FREE T4
K123379
Abbott Laboratories
Chemistry · 26d
Cleared Feb 02, 2009
IMMULITE 2000 FREE T4
K083373
Siemens Healthcare Diagnostics, Inc.
Chemistry · 80d
Cleared Aug 08, 2008
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
K080167
Siemens Healthcare Diagnostics
Chemistry · 198d
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 Mar 18, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
K962408
Nichols Institute Diagnostics
Chemistry · 270d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
K965142
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 85d
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 Feb 22, 1995
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
K944697
Organon Teknika Corp.
Chemistry · 152d
Cleared Jul 28, 1994
OPUS FT4 TEST SYSTEM
K940507
Pb Diagnostic Systems, Inc.
Chemistry · 176d

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.