Radioimmunoassay, Total Thyroxine

FDA product code CDX · 121 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1700
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-07-20 – 1996-06-13

CDX 1996-06-13

ELECSYS T4 ASSAY

Applicant Boehringer Mannheim Corp.

K number K961490

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CDX 1995-10-07

ACTIVE THYROXINE RIA

Applicant Diagnostic Systems Laboratories, Inc.

K number K954312

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CDX 1995-03-10

DELFIA NEONATAL THYROXINE KIT

Applicant Wallac OY

K number K943416

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CDX 1994-06-21

AXSYM(TM) TOTAL T4

Applicant Abbott Laboratories

K number K934384

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CDX 1993-10-18

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

Applicant Sigma Diagnostics, Inc.

K number K932980

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CDX 1993-08-26

STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO

Applicant Baxter Diagnostics, Inc.

K number K933426

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CDX 1993-07-20

IQ TT4 ASSAY

Applicant Becton Dickinson Advanced Diagnostics

K number K931295

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CDX 1993-03-18

AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT

Applicant Bio-Chem Laboratory Systems, Inc.

K number K926563

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CDX 1993-01-26

ABBOTT IMX T4

Applicant Abbott Laboratories

K number K925110

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CDX 1993-01-04

ABBOTT TDX/TDXFLX TT4

Applicant Abbott Laboratories

K number K925109

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CDX 1992-10-14

TECHNICON DAX SYSTEM THYROXINE (T4) METHOD

Applicant Heraeus Kulzer, Inc.

K number K922945

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CDX 1992-07-07

THYROXINE (T4) COATED TUBE RIA

Applicant Monobind

K number K921935

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CDX 1992-04-17

T4 EIA BEAD ASSAY

Applicant Tech-Co, Inc.

K number K920766

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CDX 1992-01-28

CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT

Applicant Incstar Corp.

K number K915235

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CDX 1991-08-12

MILENIA TOTAL T4, CATALOG: MKT41,5

Applicant Diagnostic Products Corp.

K number K912541

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CDX 1991-08-02

LUMATAG T4 CHEMILUMINESCENCE ASSAY

Applicant London Diagnostics, Inc.

K number K911985

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CDX 1991-01-17

THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K904816

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CDX 1991-01-15

CIBA CORNING ACS T4 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K905532

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CDX 1990-07-27

MICROZYME T4 ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K902922

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CDX 1990-06-20

CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4

Applicant Baxter Healthcare Corp

K number K901475

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CDX 1990-05-31

NEOCOAT T4

Applicant Neometrics, Inc.

K number K901939

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CDX 1989-10-04

TECHNICON RA SYSTEM THYROXINE T4 METHOD

Applicant Technicon Instruments Corp.

K number K894575

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CDX 1988-12-14

DELFIA THYROXINE (T4) KIT

Applicant Pharmacia, Inc.

K number K883559

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CDX 1988-02-16

FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101

Applicant Cyberfluor, Inc.

K number K874623

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CDX 1988-02-11

IMMPULSE T4 ASSAY REAGENTS

Applicant Sclavo, Inc.

K number K875081

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CDX 1987-07-21

CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K872286

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CDX 1987-06-17

DELFIA(TM) THYROXINE (T4) KIT

Applicant Lkb Instruments, Inc.

K number K871303

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CDX 1987-05-26

MICROMEDIC NEONATAL T4 KIT

Applicant Micromedic Systems

K number K871008

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CDX 1987-05-14

CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K870965

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CDX 1987-04-22

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT

Applicant Cambridge Medical Technology

K number K870573

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CDX 1986-12-16

IQ T4 IMMUNOASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K864560

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CDX 1986-04-24

MMS T4 RIA KIT

Applicant Micromedic Systems

K number K861320

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CDX 1986-02-11

STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY

Applicant American Dade

K number K860421

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CDX 1986-01-15

T-4 RIASSAY

Applicant Ria Diagnostics

K number K854798

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CDX 1985-12-05

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K854324

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CDX 1984-04-18

IMMPULSE T4 ASSAY REAGENTS

Applicant Paragon Diagnostics, Inc.

K number K840852

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CDX 1984-01-24

BIO-SCIENCE LABORATORIES T4 REAGENT

Applicant Biosan Laboratories, Inc.

K number K834023

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CDX 1984-01-18

T4 RIA

Applicant Syncor Intl. Corp.

K number K833850

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CDX 1984-01-04

RIACOAT T-4

Applicant Immuno Assay Corp.

K number K833745

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CDX 1983-09-12

T4-RIA SINGLE REAGENT

Applicant Fairlake Laboratories

K number K832468

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CDX 1983-06-30

MAGIC T4 125I RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K831533

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CDX 1983-05-18

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

Applicant Diagnostic Products Corp.

K number K831107

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CDX 1983-04-05

PHASE THYROXINE RADIOIMMUNOASSAY KIT

Applicant Medical & Scientific Designs, Inc.

K number K830642

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CDX 1982-12-09

MONOCLONAL ANTIBODY T4 RADIO-KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K823265

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CDX 1982-11-10

NML-TETRA-TUBE RIA

Applicant Nuclear Medical Laboratories, Inc.

K number K823053

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CDX 1982-11-05

BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K823004

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CDX 1982-09-13

LEECO T4 QUANT DIAGNOSTICS TEST KIT

Applicant Leeco Diagnostics, Inc.

K number K822399

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CDX 1982-06-25

ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT

Applicant Amf Biological and Diagnostics Co.

K number K821554

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CDX 1982-06-01

SPAC T4 RIA TEST KIT

Applicant Mallinckrodt Critical Care

K number K820725

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CDX 1982-05-13

ENDAB T4 ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K821141

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CDX 1982-05-05

TOTAL RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K821101

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CDX 1982-04-16

THYROXINE T4 KIT

Applicant Pcl-Ria, Inc.

K number K820886

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CDX 1981-07-10

QUANTAPHASE T-4 RIA

Applicant Bio-Rad

K number K811787

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CDX 1981-05-27

COAT-A-COUNT T4 RIA KIT

Applicant Diagnostic Products Corp.

K number K811315

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CDX 1981-04-29

125 I-T4 RIA TEST KIT

Applicant Intl. Immunoassay Laboratories, Inc.

K number K811070

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CDX 1981-04-07

T4 RIA KIT

Applicant Immuno Assay Corp.

K number K810811

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CDX 1981-01-02

IMMU-TRACE T4 RIA PROCEDURE

Applicant American Dade

K number K803046

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CDX 1980-11-24

SERUM T4 BY ENZYME IMMUNOASSAY

Applicant Worthington Diagnostic Systems

K number K802573

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CDX 1980-11-12

T4 RADIOIMMUNOASSAY KIT

Applicant American Diagnostic Corp.

K number K802469

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CDX 1980-10-31

T4-SQUIBB RIA KIT

Applicant E. R. Squibb & Sons, Inc.

K number K802456

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CDX 1980-06-09

THYROXINE RADIOIMMUNOASSAY KIT

Applicant Calbiochem-Behring Corp.

K number K801105

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CDX 1980-03-19

ANALYTE T4-THYROXINE

Applicant Technicon Instruments Corp.

K number K800385

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CDX 1980-03-19

RIA PHASE T4

Applicant Boehringer Mannheim Corp.

K number K800203

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CDX 1980-03-05

AMERLEX T-4 RIA KIT

Applicant Amersham Corp.

K number K800300

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CDX 1980-02-13

EMC-M-175, THYROXINE - 100 TUBES

Applicant Endocrine-Metabolic Center

K number K800187

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CDX 1980-02-13

AMES RIALYZE - CHROMATOGRAPHY TUBES

Applicant Miles Laboratories, Inc.

K number K800169

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CDX 1980-01-16

TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY

Applicant Nuclear Diagnostics, Inc.

K number K792599

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CDX 1979-11-27

TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT

Applicant Abbott Laboratories

K number K792188

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CDX 1979-09-27

IMMUCHEM COVALENT COAT SOLID PHASE ASSAY

Applicant Immuchem Corp.

K number K791664

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CDX 1979-09-17

VENTRE/SEP T4 TEST SET

Applicant Ventrex Laboratories, Inc.

K number K791368

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CDX 1979-09-04

DAC-CEL T4

Applicant Burroughs Wellcome Co.

K number K791231

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CDX 1979-07-30

QUANTIMUNE T-4 FIA

Applicant Bio-Rad

K number K790576

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CDX 1979-06-27

AUTOPAK TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K number K790907

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CDX 1979-06-15

CENTRIA T4 RIA TEST SET

Applicant Ventrex Laboratories, Inc.

K number K790800

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CDX 1979-05-15

NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM

Applicant Micromedic Systems

K number K790665

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CDX 1979-05-03

THYROXINE RIA KIT

Applicant Technia Diagnostics , Ltd.

K number K790495

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CDX 1979-04-26

TY RIA KIT, AUTOMATED ASSAY SYSTEM

Applicant E. R. Squibb & Sons, Inc.

K number K790477

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CDX 1979-01-26

RIA KIT, GAMMACOAT

Applicant Clinical Assays, Inc.

K number K782109

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CDX 1979-01-17

RIA KIT, NEONATAL T4

Applicant Serono Laboratories, Inc.

K number K782103

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CDX 1978-11-08

ACCUSCREEN T4

Applicant Neometrics, Inc.

K number K781222

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CDX 1978-09-27

ORTHO*T-4 RIA (PEG) KIT

Applicant Ortho Diagnostics, Inc.

K number K781483

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CDX 1978-08-14

IV VITRO GAMMADAB T4 RIA KIT

Applicant Clinical Assays, Inc.

K number K781235

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CDX 1978-08-14

MICRO THYROXINE REAGENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K781182

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CDX 1978-08-14

CLINIRIA TOTAL T-4 (RIA) TEST

Applicant Miles Laboratories, Inc.

K number K781181

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CDX 1978-07-27

IN VITRO NEONATAL T4

Applicant Clinical Assays, Inc.

K number K780854

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CDX 1978-06-14

T4-RIA KIT

Applicant Clinical Bioresearch

K number K780707

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CDX 1978-06-06

125 I-T4 RIA REAGENT

Applicant Radioimmunoassay, Inc.

K number K780672

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CDX 1978-05-03

EMIT CENTRIFICHEM THYROXINE ASSAY

Applicant Syva Co.

K number K780639

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CDX 1978-04-28

RADIOASSAY FOR TOTAL SERUM THYROXINE

Applicant Nuclear Diagnostics, Inc.

K number K780644

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CDX 1978-04-24

THYRO-ZYME-T4 ASSAY KIT

Applicant Coulter Electronics, Inc.

K number K780401

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CDX 1978-04-12

OREIA-T4

Applicant Organon, Inc.

K number K780308

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CDX 1978-03-30

STIKSEP-T4 RIA KIT

Applicant Nuclear Diagnostics, Inc.

K number K780423

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CDX 1978-03-17

REAGENTS, MANUEAL, ASSAY, THYROXINE

Applicant Syva Co.

K number K780121

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CDX 1978-03-03

ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY

Applicant Syva Co.

K number K780219

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CDX 1978-02-13

THYROXINE STDS. IN HUMAN SERUM

Applicant Pcl-Ria, Inc.

K number K780050

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CDX 1978-01-12

T4 RIA KIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K772330

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CDX 1978-01-05

RIA FOR SERUM THYROXINE

Applicant Clinical Immuno-Diagnostics

K number K771415

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CDX 1977-12-22

EMIT CENTRIFICHEM THYROXINE ASSAY

Applicant Syva Co.

K number K772170

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CDX 1977-12-20

PEDIATRIC THYROXINE TEST SYS. T4

Applicant Corning Medical & Scientific

K number K771609

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CDX 1977-11-22

IN VITRO DIAGNOSTIC REAGENT

Applicant Pcl-Ria, Inc.

K number K772096

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