Radioimmunoassay, Thyroid-Stimulating Hormone

FDA product code JLW · 238 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1690
Review panel: CH
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-20 – 2026-02-06

JLW 2026-02-06

Atellica® IM TSH3-Ultra II (TSH3ULII)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K251543

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JLW 2025-04-25

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

Applicant Siemens Healthcare Diagnostics

K number K243570

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JLW 2024-07-22

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

Applicant Genalyte, Inc.

K number K234091

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JLW 2024-04-04

ADVIA Centaur® TSH3-Ultra II (TSH3ULII)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K233050

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JLW 2023-07-13

Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K222116

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JLW 2022-11-10

Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer

Applicant Beckman Coulter, Inc.

K number K221225

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JLW 2019-04-16

Elecsys TSH

Applicant Roche Diagnostics

K number K190773

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JLW 2017-10-13

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

Applicant Boditech Med, Inc.

K number K170232

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JLW 2017-07-28

Lumipulse G TSH-III Immunoreaction Cartridges

Applicant Fujirebio Diagnostics,Inc.

K number K171103

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JLW 2017-07-14

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Applicant Shenzhen New Industries Biomedical Engineering Co., Ltd.

K number K162698

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JLW 2017-01-23

Elecsys TSH assay, cobas e 801 Immunoassay analyzer

Applicant Roche Diagnostics

K number K162606

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JLW 2016-10-21

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

Applicant Sysmex America, Inc.

K number K160541

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JLW 2016-08-18

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

Applicant Beckman Coulter, Inc.

K number K153651

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JLW 2016-05-31

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

Applicant Siemens Healthcare Diagnostics, Inc.

K number K160647

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JLW 2013-04-05

LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3

Applicant DiaSorin, Inc.

K number K130469

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JLW 2012-03-09

MICT TSH

Applicant Magnabiosciences, LLC

K number K110761

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JLW 2010-08-13

FASTPACK TSH IMMUNOASSAY

Applicant Qualigen, Inc.

K number K101390

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JLW 2009-09-03

GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

Applicant Perkinelmer, Inc.

K number K090846

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JLW 2009-05-08

ADVIA CENTAUR TSH3-ULTRA METHOD

Applicant Siemens Healthcare Diagnostics

K number K083844

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JLW 2008-12-22

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

Applicant Ortho-Clinical Diagnostics

K number K083173

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JLW 2008-10-23

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM

Applicant Ortho-Clinical Diagnostics, Inc.

K number K081543

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JLW 2008-05-23

DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691

Applicant Siemens Healthcare Diagnostics, Inc.

K number K081074

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JLW 2008-04-10

GBI TSH NEONATAL SCREENING KIT

Applicant Golden Bridge International, Inc.

K number K072458

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JLW 2008-04-04

ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300

Applicant Monobind, Inc.

K number K063437

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JLW 2006-11-29

OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM

Applicant Olympus America, Inc.

K number K062581

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JLW 2006-02-27

DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE

Applicant Dade Behring, Inc.

K number K060090

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JLW 2006-01-04

FASTPACK TSH IMMUNOASSAY

Applicant Qualigen, Inc.

K number K052301

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JLW 2004-09-16

MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

Applicant Beckman Coulter, Inc.

K number K042281

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JLW 2004-07-14

TSH-CTK-3 IRMA

Applicant DiaSorin, Inc.

K number K041014

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JLW 2003-07-25

THYRO TEST

Applicant Thryotec

K number K030912

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JLW 2002-11-25

ACCESS HYPERSENSITIVE HTSH ASSAY

Applicant Beckman Coulter, Inc.

K number K023093

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JLW 2002-07-19

CHEMWELL, ALSO KNOWN AS PROJECT 2900

Applicant Awareness Technology, Inc.

K number K013420

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JLW 2001-08-07

PRAXSYS RELIA TSH TEST

Applicant Praxsys Biosystems, Inc.

K number K011527

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JLW 2001-07-16

SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)

Applicant Biosafe Laboratories, Inc.

K number K011525

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JLW 2001-03-23

BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)

Applicant Biosafe Laboratories, Inc.

K number K003752

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JLW 2000-11-02

ACCUWELL TSH, MODEL KAW-TSH-960

Applicant Neometrics, Inc.

K number K001455

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JLW 2000-10-05

REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

Applicant Repromedix Corp.

K number K001606

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JLW 1999-06-22

TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001

Applicant Biocheck, Inc.

K number K991146

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JLW 1999-06-22

BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003

Applicant Biocheck, Inc.

K number K990993

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JLW 1999-06-02

THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

Applicant Little Nell Labs, Inc.

K number K990658

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JLW 1998-11-20

ABBOTT ARCHITECT TSH

Applicant Abbott Laboratories

K number K983442

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JLW 1998-06-05

3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K981312

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JLW 1998-04-29

ABBOTT AXSYM 3RD GENERATION TSH ASSAY

Applicant Abbott Laboratories

K number K981060

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JLW 1998-03-24

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

Applicant Alfa Biotech (Uk) , Ltd.

K number K980574

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JLW 1997-11-20

AUTODELFIA NEONATAL HTSH L KIT (B077-112)

Applicant Eg &G Wallac

K number K973276

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JLW 1997-08-29

AIA-PACK TSH 3RD-GEN ASSAY

Applicant Tosoh Medics, Inc.

K number K972586

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JLW 1997-06-24

THYROTROPIN(TSH) ELISA

Applicant Monobind

K number K971780

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JLW 1997-03-03

THYROID STIMULATING HORMONE METHOD

Applicant Dade Chemistry Systems, Inc.

K number K970393

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JLW 1996-12-16

VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K964558

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JLW 1996-11-18

BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS

Applicant Biocircuits Corp.

K number K961566

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JLW 1996-10-08

SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)

Applicant Scantibodies Laboratory, Inc.

K number K962464

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JLW 1996-09-19

TSH (MICROWELL) ELISA

Applicant Biomerica, Inc.

K number K962216

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JLW 1996-09-11

THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

Applicant Teco Diagnostics

K number K961629

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JLW 1996-07-22

ELECSYS TSH ASSAY

Applicant Boehringer Mannheim Corp.

K number K961491

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JLW 1996-07-16

NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT

Applicant Nichols Institute Diagnostics

K number K961650

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JLW 1996-04-15

THYROCHEK ONE-STEP RAPID TSH ASSAY

Applicant Franklin Diagnostics, Inc.

K number K960195

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JLW 1995-11-21

ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

Applicant Bio-Rad Laboratories, Inc.

K number K954825

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JLW 1995-07-14

AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K952211

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JLW 1995-06-29

AXSYM ULTRASENSITIVE HTSH II

Applicant Abbott Laboratories

K number K952148

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JLW 1995-06-13

CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K951796

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JLW 1995-05-02

CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY

Applicant Nichols Institute Diagnostics

K number K950921

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JLW 1995-03-13

COAT-A-COUNT NEONATAL TSH IRMA

Applicant Diagnostic Products Corp.

K number K943195

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JLW 1995-02-24

NEOSCREEN ELISA TSH

Applicant Pantex, Div. Bio-Analysis, Inc.

K number K942658

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JLW 1995-01-17

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT

Applicant Sealite Sciences, Inc.

K number K942661

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JLW 1994-12-19

IMMULITE THIRD GENERATION (MODIFICATION)

Applicant Diagnostic Products Corp.

K number K940006

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JLW 1994-12-19

RADIAS NEONATAL TSH ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K935399

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JLW 1994-12-19

IMMULITE RAPID TSH

Applicant Diagnostic Products Corp.

K number K933212

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JLW 1994-10-03

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM

Applicant Dupont Medical Products

K number K941146

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JLW 1994-10-03

ELEGANCE NEONATAL TSH ELISA

Applicant Bioclone Australia Pty , Ltd.

K number K935049

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JLW 1994-08-16

IMX ULTRASENSISTIVE HTSH II

Applicant Abbott Laboratories

K number K942566

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JLW 1994-06-21

AXSYM ULTRASENSITIVE HTSH

Applicant Abbott Laboratories

K number K934410

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JLW 1994-04-06

RADIAS 3RD GENERATION TSH IMMUNOASSAY

Applicant Bio-Rad

K number K935119

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JLW 1993-12-03

COBAS CORE TSH EIA

Applicant Roche Diagnostic Systems, Inc.

K number K930776

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JLW 1993-09-09

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT

Applicant Bio-Chem Laboratory Systems, Inc.

K number K930006

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JLW 1993-08-19

SIA THYROID STIMULATING HORMONE ELISA KIT

Applicant Sigma Chemical Co.

K number K930050

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JLW 1993-06-16

RADIAS TSH ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K931061

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JLW 1993-03-12

NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K923532

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JLW 1993-03-01

ACCESS HTSH ASSAY

Applicant Bio-Rad Laboratories, Inc.

K number K925637

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JLW 1992-12-28

BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE

Applicant Becton Dickinson Advanced Diagnostics

K number K925132

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JLW 1992-11-30

DELFIA HTSH ULTRA KIT

Applicant Wallac OY

K number K923401

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JLW 1992-09-09

DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K922701

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JLW 1992-07-21

VISTA ULTRASENSITIVE HTSH ASSAY

Applicant Syva Co.

K number K922138

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JLW 1992-07-10

KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA

Applicant Eastman Kodak Company

K number K922736

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JLW 1992-07-02

ELISA TUBE TSH TEST

Applicant Bio Clinic Co.

K number K921958

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JLW 1992-06-29

TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093

Applicant Medix Biotech, Inc.

K number K921700

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JLW 1992-06-18

VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY

Applicant Biomerieux Vitek, Inc.

K number K921816

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JLW 1992-03-26

VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS

Applicant Hycor Biomedical, Inc.

K number K920856

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JLW 1992-03-18

IMMUCHEM TSH-MW ELISA

Applicant Icn Biomedicals, Inc.

K number K920442

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JLW 1992-02-14

ENZYMUN-TEST TSH

Applicant Boehringer Mannheim Corp.

K number K915195

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JLW 1992-01-15

ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT

Applicant Medix Biotech, Inc.

K number K914756

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JLW 1991-12-13

IMMUCHEM NEONATAL TSH-MP ELISA

Applicant Icn Biomedicals, Inc.

K number K913963

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JLW 1991-09-27

STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO

Applicant Baxter Healthcare Corp

K number K912852

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JLW 1991-08-12

MAGIC LITE TSH (HS) IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K912583

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JLW 1991-06-20

NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K912324

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JLW 1991-06-20

STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Healthcare Corp

K number K912241

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JLW 1991-05-24

SRI TSH IMMUNENZYMETRIC ASSAY

Applicant Serono-Baker Diagnostics, Inc.

K number K910837

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JLW 1991-04-30

CIBA CORNING ACS TSH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K910981

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JLW 1991-04-03

MICROZYME TSH ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K910411

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JLW 1991-02-22

ECLIPSE ICA TSH

Applicant Biotope, Inc.

K number K910256

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JLW 1991-02-21

PHARMACIA DELFIA NEONATAL HTSH KIT

Applicant Pharmacia, Inc.

K number K905710

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