Radioimmunoassay, Free Thyroxine

FDA product code CEC · 88 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1695
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-03 – 2024-03-06

CEC 2024-03-06

Access Free T4

Applicant Beckman Coulter, Inc.

K number K240273

View details →

CEC 2023-04-07

Elecsys FT4 IV

Applicant Roche Diagnostics

K number K220456

View details →

CEC 2018-10-04

MAGLUMI 2000 FT4

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K number K182423

View details →

CEC 2018-09-18

Elecsys FT4 III

Applicant Roche Diagnostics

K number K181233

View details →

CEC 2017-10-27

Abbott Architect Free T4

Applicant Abbott Laboratories

K number K173122

View details →

CEC 2016-02-17

FREND™ Free T4 Test System

Applicant Nanoentek USA, Inc.

K number K152422

View details →

CEC 2013-09-13

ADVIA CENTAUR FT4, ADVIA CENTAUR T4

Applicant Siemens Healthcare Diagnostics, Inc.

K number K132249

View details →

CEC 2013-04-04

LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3

Applicant DiaSorin, Inc.

K number K121951

View details →

CEC 2012-11-27

ABBOTT ARCHITECT FREE T4

Applicant Abbott Laboratories

K number K123379

View details →

CEC 2009-02-02

IMMULITE 2000 FREE T4

Applicant Siemens Healthcare Diagnostics, Inc.

K number K083373

View details →

CEC 2008-08-08

ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS

Applicant Siemens Healthcare Diagnostics

K number K080167

View details →

CEC 2008-03-13

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

Applicant Dade Behring, Inc.

K number K073604

View details →

CEC 2007-08-21

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

Applicant Olympus Life & Material Science Europa GmbH (Irish

K number K070708

View details →

CEC 2006-03-03

DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR

Applicant Dade Behring, Inc.

K number K053531

View details →

CEC 2003-07-03

FASTPACK FREE T4 IMMUNOASSAY

Applicant Qualigen, Inc.

K number K030329

View details →

CEC 2002-04-05

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

Applicant Monobind

K number K020548

View details →

CEC 1998-11-20

ABBOTT ARCHITECT FREE T4

Applicant Abbott Laboratories

K number K983417

View details →

CEC 1998-09-24

FREE T4 MICROWELL EIA, MODEL #7019

Applicant Biomerica, Inc.

K number K982954

View details →

CEC 1998-07-14

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Applicant Beckman Instruments, Inc.

K number K982250

View details →

CEC 1998-06-29

BIOSTRIDE FREE T4 EIA TEST KIT

Applicant Biostride Diagnostics, Inc.

K number K981243

View details →

CEC 1998-04-03

BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS

Applicant Biocircuits Corp.

K number K980819

View details →

CEC 1997-12-22

SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY

Applicant Sealite Sciences, Inc.

K number K974551

View details →

CEC 1997-07-25

IMMULITE FREE T4 (2-STEP)

Applicant Diagnostic Products Corp.

K number K971792

View details →

CEC 1997-04-28

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

Applicant Dade Chemistry Systems, Inc.

K number K971141

View details →

CEC 1997-03-18

VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K965142

View details →

CEC 1997-03-18

NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT

Applicant Nichols Institute Diagnostics

K number K962408

View details →

CEC 1996-08-15

ACA PLUS FREE THYROXINE(FT4) METHOD

Applicant Dade Intl., Inc.

K number K962602

View details →

CEC 1996-06-11

ELECSYS FT4 ASSAY

Applicant Boehringer Mannheim Corp.

K number K961489

View details →

CEC 1995-12-20

AMERLITE MAB FT4 ASSAY

Applicant Kodak Clinical Diagnostics, Ltd.

K number K955097

View details →

CEC 1995-04-21

COBAS CORE FREE T3 EIA

Applicant Roche Diagnostic Systems, Inc.

K number K942376

View details →

CEC 1995-02-22

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK

Applicant Organon Teknika Corp.

K number K944697

View details →

CEC 1994-07-28

OPUS FT4 TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K940507

View details →

CEC 1994-06-21

AXSYM FREE THYROXINE ( FREE T4 )

Applicant Abbott Laboratories

K number K934544

View details →

CEC 1994-04-26

CIBA CORNING ACS FT3 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K940482

View details →

CEC 1994-01-24

COBAS(R) CORE FT4 EIA

Applicant Roche Diagnostic Systems, Inc.

K number K932607

View details →

CEC 1993-11-16

FT4 RADIOIMMUNOASSAY

Applicant Immunotech S.A.

K number K934012

View details →

CEC 1993-11-10

FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)

Applicant Heraeus Kulzer, Inc.

K number K930322

View details →

CEC 1993-10-28

STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC

Applicant Baxter Diagnostics, Inc.

K number K932912

View details →

CEC 1993-08-16

IMMULITE FREE T4

Applicant Diagnostic Products Corp.

K number K931704

View details →

CEC 1993-05-20

RADIAS FREE T4 ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K931110

View details →

CEC 1993-04-20

BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K925842

View details →

CEC 1993-03-01

NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K925649

View details →

CEC 1993-01-27

ACCESS(R) FREE T4 ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K925913

View details →

CEC 1992-11-30

VIDAS FREE THYROXINE(FT4) ASSAY

Applicant Biomerieux Vitek, Inc.

K number K925177

View details →

CEC 1992-11-16

VISTA FREE THYROXINE ASSAY

Applicant Syva Co.

K number K923572

View details →

CEC 1992-10-26

KODAK AMERLITE MAB FT3 ASSAY

Applicant Eastman Kodak Company

K number K922713

View details →

CEC 1992-07-10

ELEGANCE FT4 ELISA

Applicant Bioclone Australia Pty , Ltd.

K number K922284

View details →

CEC 1992-03-02

AMERLITE MAB FT4 ASSAY

Applicant Eastman Kodak Company

K number K920247

View details →

CEC 1991-12-17

LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY

Applicant London Diagnostics, Inc.

K number K914835

View details →

CEC 1991-11-19

SR1 FREE T4 ENZYME IMMUNOASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K912937

View details →

CEC 1991-10-07

AFFINITY FREE T4 TEST SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K912698

View details →

CEC 1991-09-10

AIA-PACK FT4

Applicant Tosoh Corp.

K number K913493

View details →

CEC 1991-06-24

MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST

Applicant Immunotech Corp.

K number K911634

View details →

CEC 1991-05-01

CIBA CORNING ACS FT4 IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K910684

View details →

CEC 1990-11-30

FLAGEN TM FREE T4

Applicant Cyberfluor, Inc.

K number K904539

View details →

CEC 1990-09-10

IMX FREE T4 CALCULATION

Applicant Abbott Laboratories

K number K903384

View details →

CEC 1990-09-10

TDX FREE T4 CALCULATION

Applicant Abbott Laboratories

K number K903383

View details →

CEC 1990-09-07

ABBOTT IMX FREE T4

Applicant Abbott Laboratories

K number K902834

View details →

CEC 1990-05-15

ENZYMUN TEST(R) FT4 (FREE THYROXINE)

Applicant Boehringer Mannheim Corp.

K number K900883

View details →

CEC 1990-03-29

FREE T4 IMMUNOASSAY KIT

Applicant Advanced Magnetics, Inc.

K number K900060

View details →

CEC 1989-11-17

FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT

Applicant Nichols Institute Diagnostics

K number K896222

View details →

CEC 1989-09-18

DELFIA FREE THYROXINE (FT4) KIT

Applicant Pharmacia, Inc.

K number K894605

View details →

CEC 1989-08-03

AMERLEX-MAB FT4 KIT

Applicant Amersham Corp.

K number K894091

View details →

CEC 1989-02-27

MODIFIED FREE T4 RADIOIMMUNOASSAY KIT

Applicant Advanced Magnetics, Inc.

K number K884753

View details →

CEC 1988-12-22

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT

Applicant Amersham Corp.

K number K883123

View details →

CEC 1988-10-25

QLIA T UPTAKE ASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K883971

View details →

CEC 1988-03-24

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)

Applicant Boots-Celltech Diagnostics, Inc.

K number K874875

View details →

CEC 1987-09-14

DIAGNOSTIC KIT FREE T3 AND FREE T4

Applicant Sclavo, Inc.

K number K870268

View details →

CEC 1987-03-19

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.

Applicant American Dade

K number K870158

View details →

CEC 1987-03-16

IQ FTI IMMUNOASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K865104

View details →

CEC 1987-03-12

IQ FREE T4 IMMUNOASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K864658

View details →

CEC 1987-02-18

SIMULTRAC FREE T4[57CO]/TSH MAB[125I]

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K864838

View details →

CEC 1986-02-11

AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA

Applicant Amersham Corp.

K number K860251

View details →

CEC 1985-09-18

SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K853628

View details →

CEC 1984-08-10

AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT

Applicant Amersham Corp.

K number K842482

View details →

CEC 1984-04-25

PHASE II FREE T4 KIT

Applicant Medical & Scientific Designs, Inc.

K number K840901

View details →

CEC 1983-09-01

CORNING MAGIC SINGLE STEP FREE T4

Applicant Corning Medical & Scientific

K number K832381

View details →

CEC 1983-01-12

THYROXINE ANALYSIS PRODUCTS/RADIO-FREE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K823264

View details →

CEC 1982-12-15

BIO MAG FREE T4 RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K823005

View details →

CEC 1982-11-29

SINGLE STEP FREE-T4 125I RADIOIMMUNO-

Applicant Corning Medical & Scientific

K number K823144

View details →

CEC 1982-11-05

COAT-A-COUNT FREE THYROXINE KIT/COMPONEN

Applicant Diagnostic Products Corp.

K number K822882

View details →

CEC 1982-06-01

FREE T4 RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K821241

View details →

CEC 1981-12-31

FREE T4 RIA TEST SET

Applicant Ventrex Laboratories, Inc.

K number K813465

View details →

CEC 1981-02-10

CODE IM 2050 AMERLEX FREE T4 RIA KIT

Applicant Amersham Corp.

K number K810231

View details →

CEC 1978-10-17

RIA DIAG. TEST KIT FOR INDEXING THYROX.

Applicant Nuclear Diagnostics, Inc.

K number K781560

View details →

CEC 1978-07-27

RIA TEST KIT SYS. DAMON KIQUISOL FREE

Applicant Damon Corp.

K number K781012

View details →

CEC 1978-01-06

IMMO PHASE FT4 ASSAY

Applicant Corning Medical & Scientific

K number K772194

View details →

CEC 1977-08-03

TRIOBEAD-125 DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K771236

View details →