FDA 510(k) Applications for Medical Device Product Code "CDX"
(Radioimmunoassay, Total Thyroxine)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K925110 | ABBOTT LABORATORIES | ABBOTT IMX T4 | 01/26/1993 |
| K925109 | ABBOTT LABORATORIES | ABBOTT TDX/TDXFLX TT4 | 01/04/1993 |
| K934384 | ABBOTT LABORATORIES | AXSYM(TM) TOTAL T4 | 06/21/1994 |
| K771309 | ABBOTT LABORATORIES | RIA FOR TOTAL THYROXINE | 08/03/1977 |
| K792188 | ABBOTT LABORATORIES | TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT | 11/27/1979 |
| K770474 | ABBOTT LABORATORIES | THYROSCREEN TM T4 DIAGNOSTIC KIT | 04/28/1977 |
| K803046 | AMERICAN DADE | IMMU-TRACE T4 RIA PROCEDURE | 01/02/1981 |
| K860421 | AMERICAN DADE | STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY | 02/11/1986 |
| K802469 | AMERICAN DIAGNOSTIC CORP. | T4 RADIOIMMUNOASSAY KIT | 11/12/1980 |
| K800300 | AMERSHAM CORP. | AMERLEX T-4 RIA KIT | 03/05/1980 |
| K821554 | AMF BIOLOGICAL AND DIAGNOSTICS CO. | ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT | 06/25/1982 |
| K933426 | BAXTER DIAGNOSTICS, INC. | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | 08/26/1993 |
| K901475 | BAXTER HEALTHCARE CORP. | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 | 06/20/1990 |
| K864560 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | IQ T4 IMMUNOASSAY | 12/16/1986 |
| K781182 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | MICRO THYROXINE REAGENT SYSTEM | 08/14/1978 |
| K823265 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | MONOCLONAL ANTIBODY T4 RADIO-KIT | 12/09/1982 |
| K770733 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | REAGENT SYSTEM, THYROXINE, ARIA | 06/24/1977 |
| K772330 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | T4 RIA KIT | 01/12/1978 |
| K904816 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM | 01/17/1991 |
| K931295 | BECTON DICKINSON ADVANCED DIAGNOSTICS | IQ TT4 ASSAY | 07/20/1993 |
| K926563 | BIO-CHEM LABORATORY SYSTEMS, INC. | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | 03/18/1993 |
| K811787 | BIO-RAD | QUANTAPHASE T-4 RIA | 07/10/1981 |
| K771135 | BIO-RAD | QUANTIMUNE NEONATAL & THYROXINE RIA | 07/14/1977 |
| K790576 | BIO-RAD | QUANTIMUNE T-4 FIA | 07/30/1979 |
| K760135 | BIO-RAD | TEST, RA, QUANTA-COUNT T-4 | 07/20/1976 |
| K823004 | BIOCLINICAL GROUP | BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT | 11/05/1982 |
| K821101 | BIOCLINICAL GROUP | TOTAL RADIOIMMUNOASSAY KIT | 05/05/1982 |
| K771414 | BIOMEDICAL LABS., INC. | T4 BY RIA DIAG. KIT | 09/22/1977 |
| K834023 | BIOSAN LABORATORIES, INC. | BIO-SCIENCE LABORATORIES T4 REAGENT | 01/24/1984 |
| K961490 | BOEHRINGER MANNHEIM CORP. | ELECSYS T4 ASSAY | 06/13/1996 |
| K800203 | BOEHRINGER MANNHEIM CORP. | RIA PHASE T4 | 03/19/1980 |
| K791231 | BURROUGHS WELLCOME CO. | DAC-CEL T4 | 09/04/1979 |
| K801105 | CALBIOCHEM-BEHRING CORP. | THYROXINE RADIOIMMUNOASSAY KIT | 06/09/1980 |
| K870573 | CAMBRIDGE MEDICAL TECHNOLOGY | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | 04/22/1987 |
| K905532 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING ACS T4 IMMUNOASSAY | 01/15/1991 |
| K872286 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY | 07/21/1987 |
| K870965 | CIBA CORNING DIAGNOSTICS CORP. | CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY | 05/14/1987 |
| K780854 | CLINICAL ASSAYS, INC. | IN VITRO NEONATAL T4 | 07/27/1978 |
| K781235 | CLINICAL ASSAYS, INC. | IV VITRO GAMMADAB T4 RIA KIT | 08/14/1978 |
| K782109 | CLINICAL ASSAYS, INC. | RIA KIT, GAMMACOAT | 01/26/1979 |
| K780707 | CLINICAL BIORESEARCH | T4-RIA KIT | 06/14/1978 |
| K761272 | CLINICAL DIAGNOSTICS, INC. | CENTRIA T4 RIA | 03/16/1977 |
| K771415 | CLINICAL IMMUNO-DIAGNOSTICS | RIA FOR SERUM THYROXINE | 01/05/1978 |
| K831533 | CORNING MEDICAL & SCIENTIFIC | MAGIC T4 125I RADIOIMMUNOASSAY | 06/30/1983 |
| K771609 | CORNING MEDICAL & SCIENTIFIC | PEDIATRIC THYROXINE TEST SYS. T4 | 12/20/1977 |
| K780401 | COULTER ELECTRONICS, INC. | THYRO-ZYME-T4 ASSAY KIT | 04/24/1978 |
| K874623 | CYBERFLUOR, INC. | FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 | 02/16/1988 |
| K761282 | DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. | DATA-TOPE T4 RIA PROCEDURE | 12/30/1976 |
| K831107 | DIAGNOSTIC PRODUCTS CORP. | COAT-A-COUNT NEONATAL T4 KIT RIA KIT | 05/18/1983 |
| K811315 | DIAGNOSTIC PRODUCTS CORP. | COAT-A-COUNT T4 RIA KIT | 05/27/1981 |
| K912541 | DIAGNOSTIC PRODUCTS CORP. | MILENIA TOTAL T4, CATALOG: MKT41,5 | 08/12/1991 |
| K770241 | DIAGNOSTIC PRODUCTS CORP. | NEONATAL T4 RIA KIT | 02/14/1977 |
| K954312 | DIAGNOSTIC SYSTEMS LABORATORIES, INC. | ACTIVE THYROXINE RIA | 10/07/1995 |
| K802456 | E. R. SQUIBB & SONS, INC. | T4-SQUIBB RIA KIT | 10/31/1980 |
| K790477 | E. R. SQUIBB & SONS, INC. | TY RIA KIT, AUTOMATED ASSAY SYSTEM | 04/26/1979 |
| K800187 | ENDOCRINE-METABOLIC CENTER | EMC-M-175, THYROXINE - 100 TUBES | 02/13/1980 |
| K832468 | FAIRLAKE LABORATORIES | T4-RIA SINGLE REAGENT | 09/12/1983 |
| K770737 | G.D. SEARLE AND CO. | REAGENT SET, T-4, CPB | 06/22/1977 |
| K770676 | G.D. SEARLE AND CO. | T-4 RIA REAGENT SET | 05/20/1977 |
| K922945 | HERAEUS KULZER, INC. | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | 10/14/1992 |
| K791664 | IMMUCHEM CORP. | IMMUCHEM COVALENT COAT SOLID PHASE ASSAY | 09/27/1979 |
| K833745 | IMMUNO ASSAY CORP. | RIACOAT T-4 | 01/04/1984 |
| K810811 | IMMUNO ASSAY CORP. | T4 RIA KIT | 04/07/1981 |
| K821141 | IMMUNOTECH CORP. | ENDAB T4 ENZYME IMMUNOASSAY KIT | 05/13/1982 |
| K902922 | IMMUNOTECH CORP. | MICROZYME T4 ENZYME IMMUNOASSAY KIT | 07/27/1990 |
| K915235 | INCSTAR CORP. | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | 01/28/1992 |
| K811070 | INTL. IMMUNOASSAY LABORATORIES, INC. | 125 I-T4 RIA TEST KIT | 04/29/1981 |
| K760227 | KALLESTAD LABORATORIES, INC. | RADIOIMMUNOASSAY | 07/26/1976 |
| K822399 | LEECO DIAGNOSTICS, INC. | LEECO T4 QUANT DIAGNOSTICS TEST KIT | 09/13/1982 |
| K871303 | LKB INSTRUMENTS, INC. | DELFIA(TM) THYROXINE (T4) KIT | 06/17/1987 |
| K911985 | LONDON DIAGNOSTICS, INC. | LUMATAG T4 CHEMILUMINESCENCE ASSAY | 08/02/1991 |
| K820725 | MALLINCKRODT CRITICAL CARE | SPAC T4 RIA TEST KIT | 06/01/1982 |
| K770156 | MALLINCKRODT CRITICAL CARE | SPAC TM T4 RIA KIT | 02/07/1977 |
| K772064 | MEDCOM DIAGNOSTICS, INC. | THYRODOT-4 ANTISERA LYOPHOLIZED | 11/14/1977 |
| K830642 | MEDICAL & SCIENTIFIC DESIGNS, INC. | PHASE THYROXINE RADIOIMMUNOASSAY KIT | 04/05/1983 |
| K771606 | MELOY LABORATORIES, INC. | IMMUNOSPOT NEONATAL T4 TEST | 09/15/1977 |
| K790907 | MICROMEDIC SYSTEMS | AUTOPAK TEST DELIVERY SYSTEM | 06/27/1979 |
| K871008 | MICROMEDIC SYSTEMS | MICROMEDIC NEONATAL T4 KIT | 05/26/1987 |
| K861320 | MICROMEDIC SYSTEMS | MMS T4 RIA KIT | 04/24/1986 |
| K790665 | MICROMEDIC SYSTEMS | NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM | 05/15/1979 |
| K800169 | MILES LABORATORIES, INC. | AMES RIALYZE - CHROMATOGRAPHY TUBES | 02/13/1980 |
| K772014 | MILES LABORATORIES, INC. | AMES T-4 STRIP TEST | 11/02/1977 |
| K781181 | MILES LABORATORIES, INC. | CLINIRIA TOTAL T-4 (RIA) TEST | 08/14/1978 |
| K760572 | MILES LABORATORIES, INC. | SERALUTE | 11/23/1976 |
| K771221 | MONOBIND | T4 RIA TEST SYSTEM | 08/04/1977 |
| K921935 | MONOBIND | THYROXINE (T4) COATED TUBE RIA | 07/07/1992 |
| K781222 | NEOMETRICS, INC. | ACCUSCREEN T4 | 11/08/1978 |
| K901939 | NEOMETRICS, INC. | NEOCOAT T4 | 05/31/1990 |
| K792599 | NUCLEAR DIAGNOSTICS, INC. | "TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY" | 01/16/1980 |
| K780644 | NUCLEAR DIAGNOSTICS, INC. | RADIOASSAY FOR TOTAL SERUM THYROXINE | 04/28/1978 |
| K780423 | NUCLEAR DIAGNOSTICS, INC. | STIKSEP-T4 RIA KIT | 03/30/1978 |
| K823053 | NUCLEAR MEDICAL LABORATORIES, INC. | NML-TETRA-TUBE RIA | 11/10/1982 |
| K780308 | ORGANON, INC. | OREIA-T4 | 04/12/1978 |
| K781483 | ORTHO DIAGNOSTICS, INC. | ORTHO*T-4 RIA (PEG) KIT | 09/27/1978 |
| K760079 | OXFORD LABORATORIES, INC. | REAGENT, THYROXINE T4 (#210) | 07/20/1976 |
| K854324 | PANTEX, DIV. BIO-ANALYSIS, INC. | PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT | 12/05/1985 |
| K840852 | PARAGON DIAGNOSTICS, INC. | IMMPULSE T4 ASSAY REAGENTS | 04/18/1984 |
| K772096 | PCL-RIA, INC. | IN VITRO DIAGNOSTIC REAGENT | 11/22/1977 |
| K780050 | PCL-RIA, INC. | THYROXINE STDS. IN HUMAN SERUM | 02/13/1978 |
| K820886 | PCL-RIA, INC. | THYROXINE T4 KIT | 04/16/1982 |
| K883559 | PHARMACIA, INC. | DELFIA THYROXINE (T4) KIT | 12/14/1988 |
| K780672 | RADIOIMMUNOASSAY, INC. | 125 I-T4 RIA REAGENT | 06/06/1978 |
| K854798 | RIA DIAGNOSTICS | T-4 RIASSAY | 01/15/1986 |
| K875081 | SCLAVO, INC. | IMMPULSE T4 ASSAY REAGENTS | 02/11/1988 |
| K782103 | SERONO LABORATORIES, INC. | RIA KIT, NEONATAL T4 | 01/17/1979 |
| K932980 | SIGMA DIAGNOSTICS, INC. | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | 10/18/1993 |
| K770726 | SQUIBB & SONS, INC. | RIA KIT, T4 CLASP | 04/28/1977 |
| K833850 | SYNCOR INTL. CORP. | T4 RIA | 01/18/1984 |
| K780219 | SYVA CO. | ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY | 03/03/1978 |
| K772170 | SYVA CO. | EMIT CENTRIFICHEM THYROXINE ASSAY | 12/22/1977 |
| K780639 | SYVA CO. | EMIT CENTRIFICHEM THYROXINE ASSAY | 05/03/1978 |
| K780121 | SYVA CO. | REAGENTS, MANUEAL, ASSAY, THYROXINE | 03/17/1978 |
| K920766 | TECH-CO, INC. | T4 EIA BEAD ASSAY | 04/17/1992 |
| K790495 | TECHNIA DIAGNOSTICS LTD. | THYROXINE RIA KIT | 05/03/1979 |
| K800385 | TECHNICON INSTRUMENTS CORP. | ANALYTE T4-THYROXINE | 03/19/1980 |
| K894575 | TECHNICON INSTRUMENTS CORP. | TECHNICON RA SYSTEM THYROXINE T4 METHOD | 10/04/1989 |
| K770940 | THE DOW CHEMICAL CO. | TOTAL THYROXINE (RIA) REAGENT SET | 06/22/1977 |
| K790800 | VENTREX LABORATORIES, INC. | CENTRIA T4 RIA TEST SET | 06/15/1979 |
| K791368 | VENTREX LABORATORIES, INC. | VENTRE/SEP T4 TEST SET | 09/17/1979 |
| K943416 | WALLAC OY | DELFIA NEONATAL THYROXINE KIT | 03/10/1995 |
| K802573 | WORTHINGTON DIAGNOSTIC SYSTEMS | SERUM T4 BY ENZYME IMMUNOASSAY | 11/24/1980 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
