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 |
| K902834 | ABBOTT LABORATORIES | ABBOTT IMX FREE T4 | 09/07/1990 |
| K934544 | ABBOTT LABORATORIES | AXSYM FREE THYROXINE ( FREE T4 ) | 06/21/1994 |
| K903384 | ABBOTT LABORATORIES | IMX FREE T4 CALCULATION | 09/10/1990 |
| K903383 | ABBOTT LABORATORIES | TDX FREE T4 CALCULATION | 09/10/1990 |
| K771236 | ABBOTT LABORATORIES | TRIOBEAD-125 DIAGNOSTIC KIT | 08/03/1977 |
| K900060 | ADVANCED MAGNETICS, INC. | FREE T4 IMMUNOASSAY KIT | 03/29/1990 |
| K884753 | ADVANCED MAGNETICS, INC. | MODIFIED FREE T4 RADIOIMMUNOASSAY KIT | 02/27/1989 |
| K870158 | AMERICAN DADE | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. | 03/19/1987 |
| K842482 | AMERSHAM CORP. | AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT | 08/10/1984 |
| K860251 | AMERSHAM CORP. | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA | 02/11/1986 |
| K894091 | AMERSHAM CORP. | AMERLEX-MAB FT4 KIT | 08/03/1989 |
| K883123 | AMERSHAM CORP. | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT | 12/22/1988 |
| K810231 | AMERSHAM CORP. | CODE IM 2050 AMERLEX FREE T4 RIA KIT | 02/10/1981 |
| K932912 | BAXTER DIAGNOSTICS, INC. | STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC | 10/28/1993 |
| K912698 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | AFFINITY FREE T4 TEST SYSTEM | 10/07/1991 |
| K925842 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM | 04/20/1993 |
| K864658 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | IQ FREE T4 IMMUNOASSAY | 03/12/1987 |
| K865104 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | IQ FTI IMMUNOASSAY | 03/16/1987 |
| K883971 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | QLIA T UPTAKE ASSAY | 10/25/1988 |
| K853628 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY | 09/18/1985 |
| K864838 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | SIMULTRAC FREE T4[57CO]/TSH MAB[125I] | 02/18/1987 |
| K823264 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | THYROXINE ANALYSIS PRODUCTS/RADIO-FREE | 01/12/1983 |
| K982250 | BECKMAN INSTRUMENTS, INC. | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 07/14/1998 |
| K931110 | BIO-RAD | RADIAS FREE T4 ENZYME IMMUNOASSAY | 05/20/1993 |
| K925913 | BIO-RAD LABORATORIES, INC. | ACCESS(R) FREE T4 ASSAY | 01/27/1993 |
| K980819 | BIOCIRCUITS CORP. | BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS | 04/03/1998 |
| K823005 | BIOCLINICAL GROUP | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT | 12/15/1982 |
| K821241 | BIOCLINICAL GROUP | FREE T4 RADIOIMMUNOASSAY KIT | 06/01/1982 |
| K922284 | BIOCLONE AUSTRALIA PTY LTD. | ELEGANCE FT4 ELISA | 07/10/1992 |
| K982954 | BIOMERICA, INC. | FREE T4 MICROWELL EIA, MODEL #7019 | 09/24/1998 |
| K132058 | BIOMERIEUX SA | VIDAS FT4 | 06/08/2015 |
| K925177 | BIOMERIEUX VITEK, INC. | VIDAS FREE THYROXINE(FT4) ASSAY | 11/30/1992 |
| K981243 | BIOSTRIDE DIAGNOSTICS, INC. | BIOSTRIDE FREE T4 EIA TEST KIT | 06/29/1998 |
| K961489 | BOEHRINGER MANNHEIM CORP. | ELECSYS FT4 ASSAY | 06/11/1996 |
| K900883 | BOEHRINGER MANNHEIM CORP. | ENZYMUN TEST(R) FT4 (FREE THYROXINE) | 05/15/1990 |
| K874875 | BOOTS-CELLTECH DIAGNOSTICS, INC. | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) | 03/24/1988 |
| K940482 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING ACS FT3 IMMUNOASSAY | 04/26/1994 |
| K910684 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING ACS FT4 IMMUNOASSAY | 05/01/1991 |
| K832381 | CORNING MEDICAL & SCIENTIFIC | CORNING MAGIC SINGLE STEP FREE T4 | 09/01/1983 |
| K772194 | CORNING MEDICAL & SCIENTIFIC | IMMO PHASE FT4 ASSAY | 01/06/1978 |
| K823144 | CORNING MEDICAL & SCIENTIFIC | SINGLE STEP FREE-T4 125I RADIOIMMUNO- | 11/29/1982 |
| K904539 | CYBERFLUOR, INC. | FLAGEN TM FREE T4 | 11/30/1990 |
| 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 |
| K781012 | DAMON CORP. | RIA TEST KIT SYS. DAMON KIQUISOL FREE | 07/27/1978 |
| K822882 | DIAGNOSTIC PRODUCTS CORP. | COAT-A-COUNT FREE THYROXINE KIT/COMPONEN | 11/05/1982 |
| K931704 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE FREE T4 | 08/16/1993 |
| 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 |
| K920247 | EASTMAN KODAK COMPANY | AMERLITE MAB FT4 ASSAY | 03/02/1992 |
| K922713 | EASTMAN KODAK COMPANY | KODAK AMERLITE MAB FT3 ASSAY | 10/26/1992 |
| K930322 | HERAEUS KULZER, INC. | FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) | 11/10/1993 |
| K911634 | IMMUNOTECH CORP. | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST | 06/24/1991 |
| K934012 | IMMUNOTECH S.A. | FT4 RADIOIMMUNOASSAY | 11/16/1993 |
| K965142 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15) | 03/18/1997 |
| K955097 | KODAK CLINICAL DIAGNOSTICS, LTD. | AMERLITE MAB FT4 ASSAY | 12/20/1995 |
| K914835 | LONDON DIAGNOSTICS, INC. | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | 12/17/1991 |
| K840901 | MEDICAL & SCIENTIFIC DESIGNS, INC. | PHASE II FREE T4 KIT | 04/25/1984 |
| 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 |
| K896222 | NICHOLS INSTITUTE DIAGNOSTICS | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT | 11/17/1989 |
| K962408 | NICHOLS INSTITUTE DIAGNOSTICS | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT | 03/18/1997 |
| K781560 | NUCLEAR DIAGNOSTICS, INC. | RIA DIAG. TEST KIT FOR INDEXING THYROX. | 10/17/1978 |
| K070708 | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 | 08/21/2007 |
| K944697 | ORGANON TEKNIKA CORP. | AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK | 02/22/1995 |
| K940507 | PB DIAGNOSTIC SYSTEMS, INC. | OPUS FT4 TEST SYSTEM | 07/28/1994 |
| K894605 | PHARMACIA, INC. | DELFIA FREE THYROXINE (FT4) KIT | 09/18/1989 |
| K030329 | Qualigen, Inc. | FASTPACK FREE T4 IMMUNOASSAY | 07/03/2003 |
| K942376 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS CORE FREE T3 EIA | 04/21/1995 |
| K932607 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBAS(R) CORE FT4 EIA | 01/24/1994 |
| K131244 | Roche Diagnostics | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | 01/27/2014 |
| K870268 | SCLAVO, INC. | DIAGNOSTIC KIT FREE T3 AND FREE T4 | 09/14/1987 |
| K974551 | SEALITE SCIENCES, INC. | SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY | 12/22/1997 |
| K912937 | SERONO-BAKER DIAGNOSTICS, INC. | SR1 FREE T4 ENZYME IMMUNOASSAY | 11/19/1991 |
| 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 |
| K925649 | SOLARCARE TECHNOLOGIES CORP,INC. | NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY | 03/01/1993 |
| K923572 | SYVA CO. | VISTA FREE THYROXINE ASSAY | 11/16/1992 |
| K913493 | TOSOH CORP. | AIA-PACK FT4 | 09/10/1991 |
| K813465 | VENTREX LABORATORIES, INC. | FREE T4 RIA TEST SET | 12/31/1981 |
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