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 |
K181233 |
Roche Diagnostics |
Elecsys FT4 III |
09/18/2018 |
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 |
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 |
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 |