FDA 510(k) Applications for Medical Device Product Code "CDP"
(Radioimmunoassay, Total Triiodothyronine)
| 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 |
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