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 |