Panels › Clinical Chemistry › Product code CEC · Class 2
Radioimmunoassay, Free Thyroxine
Regulation 862.1695
0510(k)s in 12 months (92 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in CEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 8 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 8 | 0 |
| Siemens Healthcare Diagnostics | 5 | 2 |
| Amersham Corp. | 5 | 0 |
| Beckman Coulter, Inc. | 1 | 4 |
| Abbott Laboratories HPD/ADD | 0 | 3 |
| Corning Medical & Scientific | 3 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Roche Diagnostics | 3 | 0 |
| Advanced Magnetics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2024 | K240273 | Access Free T4 Beckman Coulter, Inc. | CEC |
| Apr 7, 2023 | K220456 | Elecsys FT4 IV Roche Diagnostics | CEC |
| Oct 4, 2018 | K182423 | MAGLUMI 2000 FT4 Shenzhen New Industries Biomedical Engineering Co., Ltd., CN | CEC |
| Sep 18, 2018 | K181233 | Elecsys FT4 III Roche Diagnostics | CEC |
| Oct 27, 2017 | K173122 | Abbott Architect Free T4 Abbott Laboratories | CEC |
| Feb 17, 2016 | K152422 | FREND Free T4 Test System Nanoentek USA, Inc. | CEC |
| Jun 8, 2015 | K132058 | VIDAS FT4 Biomerieux S.A., FR | CEC |
| Nov 26, 2014 | K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT Siemens Healthcare Diagnostics, Inc. | CEC |
| Nov 26, 2014 | K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART Siemens Healthcare Diagnostics, Inc. | CEC |
| Jan 27, 2014 | K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET Roche Diagnostics | CEC |
| Sep 13, 2013 | K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 Siemens Healthcare Diagnostics, Inc. | CEC |
| Apr 4, 2013 | K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 DiaSorin, Inc. | CEC |
| Nov 27, 2012 | K123379 | ABBOTT ARCHITECT FREE T4 Abbott Laboratories | CEC |
| Feb 2, 2009 | K083373 | IMMULITE 2000 FREE T4 Siemens Healthcare Diagnostics, Inc. | CEC |
| Aug 8, 2008 | K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS Siemens Healthcare Diagnostics | CEC |
| Mar 13, 2008 | K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD Dade Behring, Inc. | CEC |
| Aug 21, 2007 | K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 Olympus Life & Material Science Europa GmbH (Irish, IE | CEC |
| Mar 3, 2006 | K053531 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR Dade Behring, Inc. | CEC |
| Jul 3, 2003 | K030329 | FASTPACK FREE T4 IMMUNOASSAY Qualigen, Inc. | CEC |
| Apr 5, 2002 | K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 Monobind | CEC |
| Nov 20, 1998 | K983417 | ABBOTT ARCHITECT FREE T4 Abbott Laboratories | CEC |
| Sep 24, 1998 | K982954 | FREE T4 MICROWELL EIA, MODEL #7019 Biomerica, Inc. | CEC |
| Jul 14, 1998 | K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc. | CEC |
| Jun 29, 1998 | K981243 | BIOSTRIDE FREE T4 EIA TEST KIT Biostride Diagnostics, Inc. | CEC |
| Apr 3, 1998 | K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS Biocircuits Corp. | CEC |
| Dec 22, 1997 | K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY Sealite Sciences, Inc. | CEC |
| Jul 25, 1997 | K971792 | IMMULITE FREE T4 (2-STEP) Diagnostic Products Corp. | CEC |
| Apr 28, 1997 | K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM Dade Chemistry Systems, Inc. | CEC |
| Mar 18, 1997 | K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) Johnson & Johnson Clinical Diagnostics, Inc. | CEC |
| Mar 18, 1997 | K962408 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT Nichols Institute Diagnostics | CEC |
| Aug 15, 1996 | K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD Dade Intl., Inc. | CEC |
| Jun 11, 1996 | K961489 | ELECSYS FT4 ASSAY Boehringer Mannheim Corp. | CEC |
| Dec 20, 1995 | K955097 | AMERLITE MAB FT4 ASSAY Kodak Clinical Diagnostics, Ltd., GB | CEC |
| Apr 21, 1995 | K942376 | COBAS CORE FREE T3 EIA Roche Diagnostic Systems, Inc. | CEC |
| Feb 22, 1995 | K944697 | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK Organon Teknika Corp. | CEC |
| Jul 28, 1994 | K940507 | OPUS FT4 TEST SYSTEM Pb Diagnostic Systems, Inc. | CEC |
| Jun 21, 1994 | K934544 | AXSYM FREE THYROXINE ( FREE T4 ) Abbott Laboratories | CEC |
| Apr 26, 1994 | K940482 | CIBA CORNING ACS FT3 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEC |
| Jan 24, 1994 | K932607 | COBAS(R) CORE FT4 EIA Roche Diagnostic Systems, Inc. | CEC |
| Nov 16, 1993 | K934012 | FT4 RADIOIMMUNOASSAY Immunotech S.A., FR | CEC |
| Nov 10, 1993 | K930322 | FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) Heraeus Kulzer, Inc. | CEC |
| Oct 28, 1993 | K932912 | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC Baxter Diagnostics, Inc. | CEC |
| Aug 16, 1993 | K931704 | IMMULITE FREE T4 Diagnostic Products Corp. | CEC |
| May 20, 1993 | K931110 | RADIAS FREE T4 ENZYME IMMUNOASSAY Bio-Rad | CEC |
| Apr 20, 1993 | K925842 | BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Mar 1, 1993 | K925649 | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY Solarcare Technologies Corp,Inc. | CEC |
| Jan 27, 1993 | K925913 | ACCESS(R) FREE T4 ASSAY Bio-Rad Laboratories, Inc. | CEC |
| Nov 30, 1992 | K925177 | VIDAS FREE THYROXINE(FT4) ASSAY Biomerieux Vitek, Inc. | CEC |
| Nov 16, 1992 | K923572 | VISTA FREE THYROXINE ASSAY Syva Co. | CEC |
| Oct 26, 1992 | K922713 | KODAK AMERLITE MAB FT3 ASSAY Eastman Kodak Company | CEC |
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