FDA Product Code
FDA Product Code CEC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1695
510(k) Clearances — 92 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240273 | Access Free T4 | Beckman Coulter, Inc. | 2024-03-06 | Traditional | PDF ↗ |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | 2023-04-07 | Traditional | PDF ↗ |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2018-10-04 | Traditional | PDF ↗ |
| K181233 | Elecsys FT4 III | Roche Diagnostics | 2018-09-18 | Traditional | PDF ↗ |
| K173122 | Abbott Architect Free T4 | Abbott Laboratories | 2017-10-27 | Special | PDF ↗ |
| K152422 | FREND Free T4 Test System | Nanoentek USA, Inc. | 2016-02-17 | Traditional | PDF ↗ |
| K132058 | VIDAS FT4 | Biomerieux S.A. | 2015-06-08 | Traditional | PDF ↗ |
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 | Traditional | PDF ↗ |
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART | Siemens Healthcare Diagnostics, Inc. | 2014-11-26 | Traditional | PDF ↗ |
| K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | Roche Diagnostics | 2014-01-27 | Traditional | PDF ↗ |
| K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | Siemens Healthcare Diagnostics, Inc. | 2013-09-13 | Traditional | PDF ↗ |
| K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | 2013-04-04 | Traditional | PDF ↗ |
| K123379 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | 2012-11-27 | Special | PDF ↗ |
| K083373 | IMMULITE 2000 FREE T4 | Siemens Healthcare Diagnostics, Inc. | 2009-02-02 | Traditional | PDF ↗ |
| K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | Siemens Healthcare Diagnostics | 2008-08-08 | Traditional | PDF ↗ |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Dade Behring, Inc. | 2008-03-13 | Traditional | PDF ↗ |
| K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 | Olympus Life & Material Science Europa GmbH (Irish | 2007-08-21 | Traditional | PDF ↗ |
| K053531 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR | Dade Behring, Inc. | 2006-03-03 | Traditional | PDF ↗ |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | Qualigen, Inc. | 2003-07-03 | Traditional | PDF ↗ |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | Monobind | 2002-04-05 | Traditional | PDF ↗ |
| K983417 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | 1998-11-20 | Traditional | PDF ↗ |
| K982954 | FREE T4 MICROWELL EIA, MODEL #7019 | Biomerica, Inc. | 1998-09-24 | Traditional | PDF ↗ |
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K981243 | BIOSTRIDE FREE T4 EIA TEST KIT | Biostride Diagnostics, Inc. | 1998-06-29 | Traditional | PDF ↗ |
| K980819 | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS | Biocircuits Corp. | 1998-04-03 | Traditional | PDF ↗ |
| K974551 | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | Sealite Sciences, Inc. | 1997-12-22 | Traditional | PDF ↗ |
| K971792 | IMMULITE FREE T4 (2-STEP) | Diagnostic Products Corp. | 1997-07-25 | Traditional | PDF ↗ |
| K971141 | FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM | Dade Chemistry Systems, Inc. | 1997-04-28 | Traditional | PDF ↗ |
| K965142 | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K962408 | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT | Nichols Institute Diagnostics | 1997-03-18 | Traditional | PDF ↗ |
| K962602 | ACA PLUS FREE THYROXINE(FT4) METHOD | Dade Intl., Inc. | 1996-08-15 | Traditional | PDF ↗ |
| K961489 | ELECSYS FT4 ASSAY | Boehringer Mannheim Corp. | 1996-06-11 | Traditional | PDF ↗ |
| K955097 | AMERLITE MAB FT4 ASSAY | Kodak Clinical Diagnostics, Ltd. | 1995-12-20 | Traditional | PDF ↗ |
| K942376 | COBAS CORE FREE T3 EIA | Roche Diagnostic Systems, Inc. | 1995-04-21 | Traditional | PDF ↗ |
| K944697 | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK | Organon Teknika Corp. | 1995-02-22 | Traditional | PDF ↗ |
| K940507 | OPUS FT4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1994-07-28 | Traditional | PDF ↗ |
| K934544 | AXSYM FREE THYROXINE ( FREE T4 ) | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K940482 | CIBA CORNING ACS FT3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K932607 | COBAS(R) CORE FT4 EIA | Roche Diagnostic Systems, Inc. | 1994-01-24 | Traditional | PDF ↗ |
| K934012 | FT4 RADIOIMMUNOASSAY | Immunotech S.A. | 1993-11-16 | Traditional | PDF ↗ |
| K930322 | FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) | Heraeus Kulzer, Inc. | 1993-11-10 | Traditional | PDF ↗ |
| K932912 | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC | Baxter Diagnostics, Inc. | 1993-10-28 | Traditional | PDF ↗ |
| K931704 | IMMULITE FREE T4 | Diagnostic Products Corp. | 1993-08-16 | Traditional | PDF ↗ |
| K931110 | RADIAS FREE T4 ENZYME IMMUNOASSAY | Bio-Rad | 1993-05-20 | Traditional | PDF ↗ |
| K925842 | BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-04-20 | Traditional | PDF ↗ |
| K925649 | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY | Solarcare Technologies Corp,Inc. | 1993-03-01 | Traditional | PDF ↗ |
| K925913 | ACCESS(R) FREE T4 ASSAY | Bio-Rad Laboratories, Inc. | 1993-01-27 | Traditional | PDF ↗ |
| K925177 | VIDAS FREE THYROXINE(FT4) ASSAY | Biomerieux Vitek, Inc. | 1992-11-30 | Traditional | PDF ↗ |
| K923572 | VISTA FREE THYROXINE ASSAY | Syva Co. | 1992-11-16 | Traditional | PDF ↗ |
| K922713 | KODAK AMERLITE MAB FT3 ASSAY | Eastman Kodak Company | 1992-10-26 | Traditional | PDF ↗ |
| K922284 | ELEGANCE FT4 ELISA | Bioclone Australia Pty , Ltd. | 1992-07-10 | Traditional | PDF ↗ |
| K920247 | AMERLITE MAB FT4 ASSAY | Eastman Kodak Company | 1992-03-02 | Traditional | PDF ↗ |
| K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | London Diagnostics, Inc. | 1991-12-17 | Traditional | PDF ↗ |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K912698 | AFFINITY FREE T4 TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-07 | Traditional | PDF ↗ |
| K913493 | AIA-PACK FT4 | Tosoh Corp. | 1991-09-10 | Traditional | PDF ↗ |
| K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | Immunotech Corp. | 1991-06-24 | Traditional | PDF ↗ |
| K910684 | CIBA CORNING ACS FT4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-05-01 | Traditional | PDF ↗ |
| K904539 | FLAGEN TM FREE T4 | Cyberfluor, Inc. | 1990-11-30 | Traditional | PDF ↗ |
| K903383 | TDX FREE T4 CALCULATION | Abbott Laboratories | 1990-09-10 | Traditional | PDF ↗ |
| K903384 | IMX FREE T4 CALCULATION | Abbott Laboratories | 1990-09-10 | Traditional | PDF ↗ |
| K902834 | ABBOTT IMX FREE T4 | Abbott Laboratories | 1990-09-07 | Traditional | PDF ↗ |
| K900883 | ENZYMUN TEST(R) FT4 (FREE THYROXINE) | Boehringer Mannheim Corp. | 1990-05-15 | Traditional | PDF ↗ |
| K900060 | FREE T4 IMMUNOASSAY KIT | Advanced Magnetics, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K896222 | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT | Nichols Institute Diagnostics | 1989-11-17 | Traditional | PDF ↗ |
| K894605 | DELFIA FREE THYROXINE (FT4) KIT | Pharmacia, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K894091 | AMERLEX-MAB FT4 KIT | Amersham Corp. | 1989-08-03 | Traditional | PDF ↗ |
| K884753 | MODIFIED FREE T4 RADIOIMMUNOASSAY KIT | Advanced Magnetics, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K883123 | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT | Amersham Corp. | 1988-12-22 | Traditional | PDF ↗ |
| K883971 | QLIA T UPTAKE ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-25 | Traditional | PDF ↗ |
| K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | Boots-Celltech Diagnostics, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K870268 | DIAGNOSTIC KIT FREE T3 AND FREE T4 | Sclavo, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K870158 | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. | American Dade | 1987-03-19 | Traditional | PDF ↗ |
| K865104 | IQ FTI IMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-16 | Traditional | PDF ↗ |
| K864658 | IQ FREE T4 IMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-03-12 | Traditional | PDF ↗ |
| K864838 | SIMULTRAC FREE T4[57CO]/TSH MAB[125I] | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-18 | Traditional | PDF ↗ |
| K860251 | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA | Amersham Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K853628 | SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-09-18 | Traditional | PDF ↗ |
| K842482 | AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT | Amersham Corp. | 1984-08-10 | Traditional | PDF ↗ |
| K840901 | PHASE II FREE T4 KIT | Medical & Scientific Designs, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K832381 | CORNING MAGIC SINGLE STEP FREE T4 | Corning Medical & Scientific | 1983-09-01 | Traditional | PDF ↗ |
| K823264 | THYROXINE ANALYSIS PRODUCTS/RADIO-FREE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-01-12 | Traditional | PDF ↗ |
| K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-12-15 | Traditional | PDF ↗ |
| K823144 | SINGLE STEP FREE-T4 125I RADIOIMMUNO- | Corning Medical & Scientific | 1982-11-29 | Traditional | PDF ↗ |
| K822882 | COAT-A-COUNT FREE THYROXINE KIT/COMPONEN | Diagnostic Products Corp. | 1982-11-05 | Traditional | PDF ↗ |
| K821241 | FREE T4 RADIOIMMUNOASSAY KIT | Bioclinical Group | 1982-06-01 | Traditional | PDF ↗ |
| K813465 | FREE T4 RIA TEST SET | Ventrex Laboratories, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K810231 | CODE IM 2050 AMERLEX FREE T4 RIA KIT | Amersham Corp. | 1981-02-10 | Traditional | PDF ↗ |
| K781560 | RIA DIAG. TEST KIT FOR INDEXING THYROX. | Nuclear Diagnostics, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K781012 | RIA TEST KIT SYS. DAMON KIQUISOL FREE | Damon Corp. | 1978-07-27 | Traditional | PDF ↗ |
| K772194 | IMMO PHASE FT4 ASSAY | Corning Medical & Scientific | 1978-01-06 | Traditional | PDF ↗ |
| K771236 | TRIOBEAD-125 DIAGNOSTIC KIT | Abbott Laboratories | 1977-08-03 | Traditional | PDF ↗ |
Product code CEC · Class II · Clinical Chemistry. Data: openFDA.