FDA 510(k) Applications for Medical Device Product Code "CEC"
(Radioimmunoassay, Free Thyroxine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123379 | ABBOTT LABORATORIES | ABBOTT ARCHITECT FREE T4 | 11/27/2012 |
| K173122 | Abbott Laboratories | Abbott Architect Free T4 | 10/27/2017 |
| K983417 | ABBOTT LABORATORIES | ABBOTT ARCHITECT FREE T4 | 11/20/1998 |
| K982250 | BECKMAN INSTRUMENTS, INC. | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 07/14/1998 |
| K980819 | BIOCIRCUITS CORP. | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS | 04/03/1998 |
| K982954 | BIOMERICA, INC. | FREE T4 MICROWELL EIA, MODEL #7019 | 09/24/1998 |
| K132058 | BIOMERIEUX SA | VIDAS FT4 | 06/08/2015 |
| K981243 | BIOSTRIDE DIAGNOSTICS, INC. | BIOSTRIDE FREE T4 EIA TEST KIT | 06/29/1998 |
| K961489 | BOEHRINGER MANNHEIM CORP. | ELECSYS FT4 ASSAY | 06/11/1996 |
| K073604 | DADE BEHRING, INC. | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | 03/13/2008 |
| K053531 | DADE BEHRING, INC. | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR | 03/03/2006 |
| K971141 | DADE CHEMISTRY SYSTEMS, INC. | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | 04/28/1997 |
| K962602 | DADE INTL., INC. | ACA PLUS FREE THYROXINE(FT4) METHOD | 08/15/1996 |
| K971792 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE FREE T4 (2-STEP) | 07/25/1997 |
| K121951 | DIASORIN, INC. | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 | 04/04/2013 |
| K965142 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | 03/18/1997 |
| K020548 | MONOBIND | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | 04/05/2002 |
| K152422 | NANOENTEK USA INC | FRENDÖ Free T4 Test System | 02/17/2016 |
| K962408 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT | 03/18/1997 |
| K070708 | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 | 08/21/2007 |
| K030329 | Qualigen, Inc. | FASTPACK FREE T4 IMMUNOASSAY | 07/03/2003 |
| K131244 | Roche Diagnostics | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | 01/27/2014 |
| K181233 | Roche Diagnostics | Elecsys FT4 III | 09/18/2018 |
| K220456 | Roche Diagnostics | Elecsys FT4 IV | 04/07/2023 |
| K974551 | SEALITE SCIENCES, INC. | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | 12/22/1997 |
| K182423 | Shenzhen New Industries Biomedical Engineering Co., Ltd | MAGLUMI 2000 FT4 | 10/04/2018 |
| K080167 | SIEMENS HEALTHCARE DIAGNOSTICS | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | 08/08/2008 |
| K132249 | Siemens Healthcare Diagnostics Inc. | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | 09/13/2013 |
| K140842 | Siemens Healthcare Diagnostics Inc. | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART | 11/26/2014 |
| K140859 | Siemens Healthcare Diagnostics Inc. | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | 11/26/2014 |
| K083373 | Siemens Healthcare Diagnostics Inc. | IMMULITE 2000 FREE T4 | 02/02/2009 |
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