Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

FDA product code KLI · 86 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: 1977-01-21 – 2016-10-18

KLI 2016-10-18

VITROS® Automation Solutions

Applicant Ortho-Clinical Diagnostics, Inc.

K number K160495

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KLI 2013-08-14

ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

Applicant Alfa Wassermann

K number K131515

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KLI 2011-04-22

GSP NEONATAL THYROXINE (T4)

Applicant Wallac Oy, A Subsidiary of Perkinelmer, Inc.

K number K103484

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KLI 2009-02-26

ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL

Applicant Siemens Healthcare Diagnostics, Inc.

K number K082638

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KLI 2003-08-22

ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

Applicant Monobind

K number K030860

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KLI 2002-12-09

ACCESS TOTAL T4 ASSAY

Applicant Beckman Coulter, Inc.

K number K023369

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KLI 2000-10-05

REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)

Applicant Repromedix Corp.

K number K001603

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KLI 2000-03-27

SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS

Applicant Syva Co., Dade Behring, Inc.

K number K000600

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KLI 1999-06-02

BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007

Applicant Biocheck, Inc.

K number K991432

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KLI 1999-02-03

OPTICOAT T4 EIA KIT

Applicant Biotecx Laboratories, Inc.

K number K982298

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KLI 1998-11-25

ABBOTT ARCHITECT TOTAL T4

Applicant Abbott Laboratories

K number K983440

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KLI 1998-06-10

ACE T4 REAGENT T4 CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K981377

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KLI 1997-10-06

ACCUWELL T4-EIA

Applicant Neometrics, Inc.

K number K972974

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KLI 1997-06-16

TOTAL THROXINE MICROPLATE EIA(225-300)

Applicant Monobind

K number K971709

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KLI 1997-05-22

DSL ACTIVE T4 EIA

Applicant Diagnostic Systems Laboratories, Inc.

K number K971269

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KLI 1997-05-16

SYNCHRON SYSTEMS THYROXINE REAGENT

Applicant Beckman Instruments, Inc.

K number K971203

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KLI 1996-12-18

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K964721

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KLI 1996-10-18

ISOLAB'S T4 TEST KIT

Applicant Isolab, Inc.

K number K951014

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KLI 1996-07-08

UBI MAGIWEL THYROXINE (T4) QUANTITATIVE

Applicant United Biotech, Inc.

K number K962211

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KLI 1995-11-20

BIOCIRCUITS IOS T4 TEST CARTRIDGE

Applicant Biocircuits Corp.

K number K953837

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KLI 1995-11-20

BIOCIRCUITS IOS T4/TU TEST CARTRIDGES

Applicant Biocircuits Corp.

K number K952751

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KLI 1995-08-24

RADIAS NEONATAL T4 ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K951321

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KLI 1995-06-29

T4 MICROWELL EIA (ENZYME IMMUNOASSAY0

Applicant Biomerica, Inc.

K number K950588

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KLI 1995-02-22

RADIAS TOTAL T4 ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K946163

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KLI 1994-12-09

THYROXINE ENZYME IMMUNOASSAY

Applicant Diagnostic Reagents, Inc.

K number K944703

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KLI 1994-10-20

CEDIA T4 MAB ASSAY

Applicant Microgenics Corp.

K number K943019

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KLI 1994-07-28

CEDIA T4 MAB ASSAY

Applicant Microgenics Corp.

K number K942575

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KLI 1994-04-26

CEDIA T4 MAB ASSAY

Applicant Microgenics Corp.

K number K941042

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KLI 1994-03-03

CEDIA T4 MAB ASSAY MODIFICATION

Applicant Microgenics Corp.

K number K935880

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KLI 1994-01-24

COBAS (R) CORE T4 EIA

Applicant Roche Diagnostic Systems, Inc.

K number K932605

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KLI 1993-06-15

ACCESS(R) THYROXINE ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K926475

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KLI 1993-05-13

VIDAS THYROXINE (T4) ASSAY (T4)

Applicant Biomerieux Vitek, Inc.

K number K926393

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KLI 1992-09-18

VISTA THYROXINE (T-4) ASSAY -- MODIFICATION

Applicant Syva Co.

K number K922433

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KLI 1992-06-24

THYROXINE (FPIA) KIT

Applicant Tudor Laboratories, Inc.

K number K921904

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KLI 1992-03-27

MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K920712

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KLI 1991-12-09

CEDIA T4

Applicant Boehringer Mannheim Corp.

K number K915194

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KLI 1991-09-25

TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES

Applicant Technicon Instruments Corp.

K number K912616

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KLI 1991-08-16

SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)

Applicant Serono-Baker Diagnostics, Inc.

K number K911217

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KLI 1991-04-16

IMMULITE(TM) TOTAL T4

Applicant Cirrus Diagnostics, Inc.

K number K910261

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KLI 1990-08-23

IL THYROXINE (T4) ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K903095

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KLI 1990-03-29

NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K897072

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KLI 1990-03-19

OPUS T4 TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K897193

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KLI 1990-03-15

THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT

Applicant Medix Biotech, Inc.

K number K897144

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KLI 1990-03-09

AIA-PACK T4

Applicant Tosoh Corp.

K number K896982

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KLI 1990-01-30

VITRO T4-EIA-XT

Applicant In Vitro Diagnostics, Inc.

K number K896865

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KLI 1989-12-12

D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.

Applicant Photec Diagnostics, Inc.

K number K896329

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KLI 1989-05-22

T4 CLASP-BEAD EIA KIT

Applicant Biotecx Laboratories, Inc.

K number K892853

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KLI 1989-04-14

EMIT CONVENIENCE PACK: THYROXINE ASSAY

Applicant Syva Co.

K number K890831

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KLI 1989-02-23

THYROXINE MICROASSAY

Applicant Diamedix Corp.

K number K884260

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KLI 1989-02-17

ACA THYROXINE (T4 E) METHOD

Applicant The DU Pont Co.

K number K885258

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KLI 1989-02-17

EMIT THYROXINE ASSAY

Applicant Syva Co.

K number K885141

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KLI 1989-01-27

ANALYST THYROXINE (T4) ROTOR

Applicant The DU Pont Co.

K number K884700

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KLI 1988-12-09

MODIFIED CEDIA TOTAL T4 ASSAY

Applicant Microgenics Corp.

K number K884634

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KLI 1988-05-27

EMIT CONVENIENCE PACK: THYROXINE ASSAY

Applicant Syva Co.

K number K881357

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KLI 1988-03-24

EMIT THYROXINE ASSAY

Applicant Syva Co.

K number K880620

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KLI 1988-03-16

VISION(R) THYROXINE (T4)

Applicant Abbott Laboratories

K number K880662

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KLI 1988-02-11

T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE

Applicant Serono Diagnostics, Inc.

K number K874866

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KLI 1987-12-18

CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)

Applicant Ciba Corning Diagnostics Corp.

K number K874603

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KLI 1987-11-05

AMERLITE TT4 ASSAY (240/480/144 TEST KITS)

Applicant Amersham Corp.

K number K873976

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KLI 1987-10-29

AFFINITY TOTAL THYROXINE IMMUNIT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K873518

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KLI 1987-08-13

IMMUBEAD T4 ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K872192

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KLI 1986-10-14

CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)

Applicant Ciba Corning Diagnostics Corp.

K number K862233

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KLI 1986-02-06

V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT

Applicant V-Tech, Inc.

K number K854971

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KLI 1985-07-22

CEDIA TOTAL T4 ASSAY

Applicant Microgenics Corp.

K number K852164

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KLI 1984-05-22

TERUMO SENSIBEAD THYROXINE EIA KIT

Applicant Terumo Medical Corp.

K number K841601

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KLI 1984-05-22

TECHNICON RA-1000 SYS T4-THYROXINE

Applicant Technicon Instruments Corp.

K number K841576

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KLI 1984-04-04

VENTREZYME T4 IMMUNOASSAY T4

Applicant Vxr, Inc.

K number K840473

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KLI 1984-03-30

THYROXINE EMIA

Applicant Collaborative Research, Inc.

K number K840241

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KLI 1984-03-15

RA-1000 SYS-T4(THYROXINE)SERUM ANAL

Applicant Technicon Instruments Corp.

K number K834102

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KLI 1984-03-05

STRATUS TOTAL THYROXINE FLUOROMETRIC

Applicant American Dade

K number K834210

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KLI 1983-04-06

TDX THYROXINE

Applicant Abbott Laboratories

K number K830683

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KLI 1983-04-05

FEKAL CON-TRATE SYSTEM

Applicant Trend Scientific, Inc.

K number K830769

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KLI 1983-02-07

PARAMOUNT THYROXINE ASSAY

Applicant Syva Co.

K number K830136

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KLI 1983-01-12

SOPHEIA THYROXINE EIA KIT

Applicant Diagnostic Products Corp.

K number K823751

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KLI 1982-11-08

SYVA ADVANCE THYROXINE ASSAY

Applicant Syva Co.

K number K823034

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KLI 1982-04-06

ENZYMUNE-TEST T4

Applicant Icl Scientific

K number K820750

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KLI 1981-03-17

EMIT-TFG PRISMA THYROXINE ASSAY

Applicant Syva Co.

K number K810586

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KLI 1980-12-10

OREIA-Q-TY, ENZYME IMMUNOASSAY

Applicant Organon, Inc.

K number K802693

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KLI 1980-07-08

APPLICATION OF EMIT AED ASSAYS

Applicant Syva Co.

K number K801475

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KLI 1980-06-30

EMIT AAII THYROXINE ASSAY

Applicant Syva Co.

K number K801288

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KLI 1980-03-19

SMAC SYSTEM, T4 METHOD

Applicant Technicon Instruments Corp.

K number K800384

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KLI 1979-08-10

A-GENT QUANTICHROM T4 11A

Applicant Abbott Laboratories

K number K790848

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KLI 1979-05-25

EMIT CFA THYROXINE ASSAY

Applicant Syva Co.

K number K790686

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KLI 1979-02-01

EMIT THYROXINE ASSAY

Applicant Syva Co.

K number K782085

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KLI 1978-12-04

COMPUTER, 3500, GILFORD SYSTEM

Applicant Syva Co.

K number K781828

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KLI 1977-01-21

ENIT ABA THYROXINE ASSAY

Applicant Syva Co.

K number K770070

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