Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
CEC — Predicate Candidate Screening
92 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
238 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240273 | Access Free T4 | Beckman Coulter, Inc. | 2024-03-06 | 35 | 0 |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023-04-07 | 414 | 0 |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 | 28 | 0 |
| K181233 | Elecsys FT4 III | Roche Diagnostics | 2018-09-18 | 132 | 0 |
| K173122 | Abbott Architect Free T4 | Abbott Laboratories | 2017-10-27 | 28 | 0 |
| K152422 | FREND™ Free T4 Test System | Nanoentek USA, Inc. | 2016-02-17 | 175 | 0 |
| K132058 | VIDAS FT4 | Biomerieux S.A. | 2015-06-08 | 705 | 0 |
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 | 237 | 3 |
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 | 238 | 2 |
| K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | Roche Diagnostics | 2014-01-27 | 271 | 0 |
| K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | Siemens Healthcare Diagnostics, Inc. | 2013-09-13 | 56 | 0 |
| K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROI | DiaSorin, Inc. | 2013-04-04 | 275 | 0 |
| K123379 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | 2012-11-27 | 26 | 0 |
| K083373 | IMMULITE 2000 FREE T4 | Siemens Healthcare Diagnostics, Inc. | 2009-02-02 | 80 | 0 |
| K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | Siemens Healthcare Diagnostics | 2008-08-08 | 198 | 0 |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION F | Dade Behring, Inc. | 2008-03-13 | 83 | 7 |
| K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MOD | Olympus Life & Material Science Europa GmbH (Irish | 2007-08-21 | 160 | 0 |
| K053531 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LO | Dade Behring, Inc. | 2006-03-03 | 74 | 0 |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | Qualigen, Inc. | 2003-07-03 | 153 | 1 |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | Monobind | 2002-04-05 | 45 | 0 |
| K983417 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | 1998-11-20 | 52 | 2 |
| K982954 | FREE T4 MICROWELL EIA, MODEL #7019 | Biomerica, Inc. | 1998-09-24 | 31 | 0 |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1998-07-14 | 18 | 3 |
| K981243 | BIOSTRIDE FREE T4 EIA TEST KIT | Biostride Diagnostics, Inc. | 1998-06-29 | 84 | 0 |
| K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRC | Biocircuits Corp. | 1998-04-03 | 31 | 0 |
| K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | Sealite Sciences, Inc. | 1997-12-22 | 18 | 0 |
| K971792 | IMMULITE FREE T4 (2-STEP) | Diagnostic Products Corp. | 1997-07-25 | 71 | 0 |
| K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | Dade Chemistry Systems, Inc. | 1997-04-28 | 31 | 0 |
| K962408 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT | Nichols Institute Diagnostics | 1997-03-18 | 270 | 0 |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM. | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | 85 | 0 |
| K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD | Dade Intl., Inc. | 1996-08-15 | 44 | 0 |
| K961489 | ELECSYS FT4 ASSAY | Boehringer Mannheim Corp. | 1996-06-11 | 54 | 0 |
| K955097 | AMERLITE MAB FT4 ASSAY | Kodak Clinical Diagnostics, Ltd. | 1995-12-20 | 43 | 0 |
| K942376 | COBAS CORE FREE T3 EIA | Roche Diagnostic Systems, Inc. | 1995-04-21 | 338 | 0 |
| K944697 | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK | Organon Teknika Corp. | 1995-02-22 | 152 | 0 |
| K940507 | OPUS FT4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1994-07-28 | 176 | 0 |
| K934544 | AXSYM FREE THYROXINE ( FREE T4 ) | Abbott Laboratories | 1994-06-21 | 272 | 1 |
| K940482 | CIBA CORNING ACS FT3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-04-26 | 83 | 0 |
| K932607 | COBAS(R) CORE FT4 EIA | Roche Diagnostic Systems, Inc. | 1994-01-24 | 241 | 0 |
| K934012 | FT4 RADIOIMMUNOASSAY | Immunotech S.A. | 1993-11-16 | 90 | 0 |
| K930322 | FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) | Heraeus Kulzer, Inc. | 1993-11-10 | 292 | 0 |
| K932912 | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC | Baxter Diagnostics, Inc. | 1993-10-28 | 134 | 0 |
| K931704 | IMMULITE FREE T4 | Diagnostic Products Corp. | 1993-08-16 | 132 | 0 |
| K931110 | RADIAS FREE T4 ENZYME IMMUNOASSAY | Bio-Rad | 1993-05-20 | 78 | 0 |
| K925842 | BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-04-20 | 153 | 0 |
| K925649 | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY | Solarcare Technologies Corp,Inc. | 1993-03-01 | 112 | 0 |
| K925913 | ACCESS(R) FREE T4 ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-27 | 65 | 0 |
| K925177 | VIDAS FREE THYROXINE(FT4) ASSAY | Biomerieux Vitek, Inc. | 1992-11-30 | 47 | 0 |
| K923572 | VISTA FREE THYROXINE ASSAY | Syva Co. | 1992-11-16 | 122 | 0 |
| K922713 | KODAK AMERLITE MAB FT3 ASSAY | Eastman Kodak Company | 1992-10-26 | 143 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda