FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K983439 |
ABBOTT LABORATORIES |
ABBOTT ARCHITECT FREE T3 |
11/20/1998 |
K983434 |
ABBOTT LABORATORIES |
ABBOTT ARCHITECT TOTAL T3 |
11/20/1998 |
K880087 |
ABBOTT LABORATORIES |
ABBOTT IMX T3 |
04/18/1988 |
K894238 |
ABBOTT LABORATORIES |
ABBOTT TDX TOTAL T3 PLUS |
10/31/1989 |
K963827 |
ABBOTT LABORATORIES |
AXSYM FREE TRIIODOTHYRONINE (FREE T3) |
10/30/1996 |
K934517 |
ABBOTT LABORATORIES |
AXSYM TOTAL T3 |
06/21/1994 |
K903432 |
ABBOTT LABORATORIES |
IMX FREE T3 CALCULATION |
09/07/1990 |
K905261 |
ABBOTT LABORATORIES |
IMX FREE TRIIODOTHYRONINE |
01/23/1991 |
K963833 |
ABBOTT LABORATORIES |
IMX FREE TRIIODOTHYRONINE (FREE T3) |
10/30/1996 |
K770201 |
ABBOTT LABORATORIES |
T3 RIA (PEG) DIAGNOSTIC KIT |
04/05/1977 |
K803261 |
ABBOTT LABORATORIES |
T3 RIABEAD DIAGNOSTIC KIT |
01/15/1981 |
K903433 |
ABBOTT LABORATORIES |
TDX FREE T3 CALCULATION |
10/12/1990 |
K851676 |
ABBOTT LABORATORIES |
TDX TOTAL T3 |
05/20/1985 |
K894200 |
ADVANCED MAGNETICS, INC. |
FREE T3 RADIOIMMUNOASSAY KIT |
09/25/1989 |
K974027 |
ALFA BIOTECH (UK) LTD. |
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK |
02/02/1998 |
K780492 |
ALPHA GAMMA LABORATORY |
GAMMA STIK 125I T3 UPTAKE KIT |
04/28/1978 |
K842590 |
AMERICAN BIO-SCIENCE LABORATORIES |
AMER. BIO-SCIENCE LAB T3 REAGENTS |
08/10/1984 |
K802470 |
AMERICAN DIAGNOSTIC CORP. |
T3 RADIOIMMUNOASSAY KIT |
11/12/1980 |
K830980 |
AMERSHAM CORP. |
AMERLEX FREE T-3 RIA KIT |
05/25/1983 |
K800374 |
AMERSHAM CORP. |
AMERLEX T-3 RIA KIT |
03/12/1980 |
K842949 |
AMERSHAM CORP. |
AMERLEX-M FREE T-3 RIA |
09/05/1984 |
K860252 |
AMERSHAM CORP. |
AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA |
02/11/1986 |
K885195 |
AMERSHAM CORP. |
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT |
02/08/1989 |
K873858 |
AMERSHAM CORP. |
AMERLITE TT3 ASSAY, LAN.0003/1003/2003 |
11/03/1987 |
K881373 |
AMERSHAM CORP. |
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT |
05/27/1988 |
K772122 |
ANTIBODIES INC. |
T3 RIA KIT |
11/17/1977 |
K883479 |
BAXTER HEALTHCARE CORP. |
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME |
10/25/1988 |
K894993 |
BAXTER HEALTHCARE CORP. |
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. |
10/13/1989 |
K962355 |
BAYER CORP. |
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) |
07/12/1996 |
K840959 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
FREE T3 SOLID PHASE RADIOIMMUNOASSAY |
04/18/1984 |
K800436 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
T3 SOLID PHASE RADIOIMMUNOASSAY KIT |
03/19/1980 |
K780787 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT |
06/06/1978 |
K973966 |
BECKMAN INSTRUMENTS, INC. |
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
10/31/1997 |
K953160 |
BEHRING DIAGNOSTICS, INC. |
OPUS T3 |
08/24/1995 |
K831434 |
BERWICK MEDICAL PRODUCTS, INC. |
ISO-SEP SYSTEM |
06/30/1983 |
K790960 |
BIO-RAD |
QUANTIMUNE T-3 FIA |
08/10/1979 |
K770648 |
BIO-RAD |
QUANTIMUNE T-3 RIA |
06/14/1977 |
K960913 |
BIO-RAD LABORATORIES, INC. |
ACCESS FREE T3 ASSAY |
03/29/1996 |
K955435 |
BIO-RAD LABORATORIES, INC. |
ACCESS TOTAL T3 ASSAY (MODIFICATION) |
01/24/1996 |
K940833 |
BIO-RAD LABORATORIES, INC. |
ACCESS(R) TOTAL T3 |
09/07/1994 |
K991311 |
BIOCHECK, INC. |
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 |
06/02/1999 |
K960412 |
BIOMERICA, INC. |
T-3 MICROWELL EIA MODEL 7013 |
03/19/1996 |
K934764 |
BIOMERIEUX VITEK, INC. |
"VIDAS T3" ASSAY |
03/22/1994 |
K981824 |
BIOTECX LABORATORIES, INC. |
OPTICOAT T3 EIA KIT |
12/22/1998 |
K893620 |
BIOTECX LABORATORIES, INC. |
T3 CLASP-BEAD EIA KIT |
08/11/1989 |
K963127 |
BOEHRINGER MANNHEIM CORP. |
ELECSYS FT3 |
12/16/1996 |
K962508 |
BOEHRINGER MANNHEIM CORP. |
ELECSYS T3 |
08/15/1996 |
K896900 |
BOEHRINGER MANNHEIM CORP. |
ENZYMUN TEST R T3 |
02/08/1990 |
K962760 |
BOEHRINGER MANNHEIM CORP. |
ENZYMUN-TEST FT3 |
11/29/1996 |
K791232 |
BURROUGHS WELLCOME CO. |
DAC-CEL T3 |
09/04/1979 |
K801123 |
CALBIOCHEM-BEHRING CORP. |
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM |
06/09/1980 |
K873737 |
CAMBRIDGE MEDICAL TECHNOLOGY |
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY |
11/24/1987 |
K870968 |
CANADIAN BIOCLINICAL, LTD. |
TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT |
06/22/1987 |
K915792 |
CASCO STANDARDS |
DOCUMENT CK ISOENZYMES CONTROL |
02/06/1992 |
K991692 |
CHIRON DIAGNOSTICS CORP. |
CHIRON DIAGNOSTICS ACS: 180 FT3 |
06/18/1999 |
K932747 |
CIBA CORNING DIAGNOSTICS CORP. |
CIBA CORNING ACS FREE T3 IMMUNOASSAY |
12/03/1993 |
K873945 |
CIBA CORNING DIAGNOSTICS CORP. |
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY |
11/23/1987 |
K905214 |
CIRRUS DIAGNOSTICS, INC. |
IMMULITE (TM) TOTAL T3 |
02/01/1991 |
K772108 |
CLINICAL ASSAYS, INC. |
IN VITRO T3 RIA TEST |
11/17/1977 |
K780499 |
CLINICAL BIORESEARCH |
CBR-T3RIA KIT |
05/04/1978 |
K780018 |
CLINICAL IMMUNO-DIAGNOSTICS |
THYRO-INDICATOR T-3 125I |
02/07/1978 |
K840222 |
CORNING MEDICAL & SCIENTIFIC |
CORNING IMMO PHASE FREE T3 |
05/07/1984 |
K832353 |
CORNING MEDICAL & SCIENTIFIC |
CORNING'S MAGIC T3(125I) RADIOIMMUNO- |
08/31/1983 |
K905656 |
CYBERFLUOR, INC. |
FLAGEN TRIIODOTHYRONINE (T3) ASSAY |
01/23/1991 |
K770918 |
DAMON CORP. |
LIQUI SOL T4 RIA TEST KIT |
06/17/1977 |
K832164 |
DIAGNOSTIC PRODUCTS CORP. |
COAT-A-COUNT FREE T3 RIA KIT |
10/27/1983 |
K812246 |
DIAGNOSTIC PRODUCTS CORP. |
COAT-A-COUNT T3 RIA KIT |
08/20/1981 |
K974634 |
DIAGNOSTIC PRODUCTS CORP. |
IMMULITE FREE T3 |
01/02/1998 |
K914467 |
DIAGNOSTIC PRODUCTS CORP. |
MILENIA TOTAL T3 |
02/06/1992 |
K895840 |
DIAGNOSTIC PRODUCTS CORP. |
MILENIA(TM) TOTAL T4 (MKT41,5) |
10/19/1989 |
K840050 |
DIAGNOSTIC PRODUCTS CORP. |
SOPHEIA T3 EIA KIT |
03/19/1984 |
K821725 |
DIAGNOSTIC REAGENTS, INC. |
T3 DIAGNOSTIC KIT RIA |
06/24/1982 |
K820251 |
DIAGNOSTIC REAGENTS, INC. |
T4 DIAGNOSTIC KIT |
05/05/1982 |
K960550 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
ACTIVE T3 RIA |
03/06/1996 |
K971270 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
DSL ACTIVE T3 EIA |
05/22/1997 |
K771142 |
E. R. SQUIBB & SONS, INC. |
T3 CLASP RIA KIT |
07/14/1977 |
K810211 |
E. R. SQUIBB & SONS, INC. |
T3 RIA KIT |
02/10/1981 |
K802883 |
E. R. SQUIBB & SONS, INC. |
T3-SQUIBB RIA KIT |
12/19/1980 |
K922771 |
EASTMAN KODAK COMPANY |
KODAK AMERLEX MAB FT3 ASSAY |
10/14/1992 |
K810351 |
ENDOCRINE-METABOLIC CENTER |
RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE |
02/23/1981 |
K832469 |
FAIRLAKE LABORATORIES |
T3-RIA SINGLE REAGENT |
09/12/1983 |
K770738 |
G.D. SEARLE AND CO. |
REAGENT, T-3 UPTAKE |
06/22/1977 |
K770739 |
G.D. SEARLE AND CO. |
SERUM SET, THYROID CONTROL |
06/22/1977 |
K770677 |
G.D. SEARLE AND CO. |
T-3 RIA REAGENT SET |
05/20/1977 |
K923258 |
HERAEUS KULZER, INC. |
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE |
09/23/1992 |
K771623 |
HOFFMANN-LA ROCHE, INC. |
T3 RIA |
09/20/1977 |
K820763 |
ICL SCIENTIFIC |
ENZYM-LINKED T3 |
04/15/1982 |
K791663 |
IMMUCHEM CORP. |
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY |
10/01/1979 |
K811213 |
IMMUNO ASSAY CORP. |
T3 (RIA) KIT |
05/29/1981 |
K834049 |
IMMUNOTECH CORP. |
ENDAB T3 |
01/30/1984 |
K872191 |
IMMUNOTECH CORP. |
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT |
08/13/1987 |
K904820 |
IMMUNOTECH CORP. |
MICROZYME T3 ENZYME IMMUNOASSAY KIT |
12/18/1990 |
K791317 |
IREX CORP. |
IREX REAL TIME PHASED ARRAY SYSTEM |
09/17/1979 |
K970016 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) |
01/30/1997 |
K964310 |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) |
11/27/1996 |
K812611 |
KALLESTAD LABORATORIES, INC. |
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO |
10/02/1981 |
K770520 |
KALLESTAD LABORATORIES, INC. |
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3 |
06/03/1977 |
K834348 |
LEECO DIAGNOSTICS, INC. |
LEECO T3-QUANT DIAG. KIT |
02/21/1984 |
K830808 |
LEECO DIAGNOSTICS, INC. |
LEECO T3-RIA DIAGNOSTIC KIT |
04/08/1983 |
K864452 |
LKB INSTRUMENTS, INC. |
DELFIA(TM) TRIIODOTHYRONINE (T3) KIT |
02/02/1987 |
K801125 |
MALLINCKRODT CRITICAL CARE |
SPAC T3 RIA TEST KIT |
06/09/1980 |
K831064 |
MEDICAL & SCIENTIFIC DESIGNS, INC. |
PHASE II T3 RADIOIMMUNOASSAY KIT |
05/09/1983 |
K925436 |
MEDIX BIOTECH, INC. |
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT |
12/28/1992 |
K904098 |
MICROGENICS CORP. |
CEDIA TOTAL T3 ASSAY |
09/27/1990 |
K791375 |
MICROMEDIC SYSTEMS |
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM |
10/11/1979 |
K790581 |
MILES LABORATORIES, INC. |
CHROMATOGRAPHY TUBES |
05/15/1979 |
K771220 |
MONOBIND |
T3 RIA TEST SYSTEM |
08/04/1977 |
K971779 |
MONOBIND |
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA |
06/16/1997 |
K926345 |
MONOBIND |
TRIODOTHYRONINE (TC) COATED TUBE RIA |
02/25/1993 |
K931600 |
NICHOLS INSTITUTE |
CHEMILUMINESCENCE FREE T3 IMMUNOASSAY |
09/08/1993 |
K965058 |
NICHOLS INSTITUTE DIAGNOSTICS |
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT |
03/11/1997 |
K923015 |
NICHOLS INSTITUTE DIAGNOSTICS |
TOTAL T3 CHEMILUMINESCENCE ASSAY |
09/02/1992 |
K780292 |
NUCLEAR DIAGNOSTICS, INC. |
TRIA-PEG RIA DIAG. KIT |
03/02/1978 |
K772177 |
NUCLEAR MEDICAL LABORATORIES, INC. |
TRI-TAB-RIA |
12/22/1977 |
K944808 |
ORGANON TEKNIKA CORP. |
IMX T3 ASSAY |
12/09/1994 |
K781481 |
ORTHO DIAGNOSTICS, INC. |
ORTHO*T-3 RIA (PEG) KIT |
09/27/1978 |
K760078 |
OXFORD LABORATORIES, INC. |
REAGENT, RIA TRIIODOTHYRONINE T3 (#200) |
07/20/1976 |
K905410 |
PB DIAGNOSTIC SYSTEMS, INC. |
OPUS T3 TEST SYSTEM |
02/04/1991 |
K803180 |
PCL-RIA, INC. |
1-125 LABELED TRIIODOTHYRONINE(T3) |
01/09/1981 |
K781284 |
PCL-RIA, INC. |
RABBIT ANTIBODY TO HUMAN T3 |
08/31/1978 |
K812666 |
PCL-RIA, INC. |
THYROXINE (T4) 125I |
10/02/1981 |
K883810 |
PHARMACIA, INC. |
DELFIA TRIIODOTHYRONINE (T3) KIT |
12/02/1988 |
K792539 |
RADIOIMMUNOASSAY, INC. |
TRIIODOTHYRONINE RIA SYSTEM |
01/16/1980 |
K001607 |
REPROMEDIX CORP. |
REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) |
10/05/2000 |
K852537 |
RIA DIAGNOSTICS |
T-3 RIASSAY |
08/12/1985 |
K932608 |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
COBAS(R) CORE T3 EIA |
12/03/1993 |
K881214 |
SCLAVO, INC. |
IMMPULSE T, ASSAY REAGENTS |
05/27/1988 |
K880388 |
SERONO DIAGNOSTICS, INC. |
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE |
03/03/1988 |
K910737 |
SERONO-BAKER DIAGNOSTICS, INC. |
SRI T3 IMMOENZYMETRIC ASSAY |
05/01/1991 |
K952557 |
SIGMA DIAGNOSTICS, INC. |
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS |
01/24/1996 |
K760057 |
SMITH KLINE DIAGNOSTICS, INC. |
TEST, RIA, TRIODOTHYRONINE |
09/13/1976 |
K833853 |
SYNCOR INTL. CORP. |
T3 RIA |
02/04/1984 |
K923571 |
SYVA CO. |
VISTA TRIIODOTHYRONINE ASSAY |
10/15/1992 |
K801843 |
TECHNIA DIAGNOSTICS LTD. |
T3(125) RADIOIMMUNOASSAY KIT |
09/16/1980 |
K810798 |
TECHNICON INSTRUMENTS CORP. |
TECHNICON STAR SYSTEM T3 RIA METHOD |
04/07/1981 |
K897001 |
TOSOH CORP. |
TOSOH AIA-PACK T3 |
03/09/1990 |
K991252 |
TOSOH MEDICS, INC. |
AIA-PACK FT3 ASSAY |
05/11/1999 |
K963687 |
TOSOH MEDICS, INC. |
AIA-PACK FT3 ASSAY |
11/08/1996 |
K936229 |
TOSOH MEDICS, INC. |
AIA-PACK TT3 ASSAY |
07/14/1994 |
K761305 |
UNION CARBIDE CORP. |
CENTRIA T3 RIA |
12/30/1976 |
K961236 |
UNITED BIOTECH, INC. |
UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE |
05/30/1996 |
K790908 |
VENTREX LABORATORIES, INC. |
RIA, TEST SET CENTRIA T3 |
06/27/1979 |
K791588 |
VENTREX LABORATORIES, INC. |
VENTRE/SEP T3 TEST SET |
09/27/1979 |
K853703 |
VXR, INC. |
VENTREZYME T3 IMMUNOASSAY T3 |
10/04/1985 |