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 1991-01-31

IMMULITE HS-TSH

Applicant Cirrus Diagnostics, Inc.

K number K905769

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JLW 1990-12-18

ELEGANCE TSH ELISA

Applicant Bioclone Australia Pty , Ltd.

K number K905099

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JLW 1990-11-02

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

Applicant Amersham Corp.

K number K904666

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JLW 1990-10-26

EZ-BEAD TSH ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K903725

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JLW 1990-10-12

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM

Applicant Nichols Institute

K number K903391

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JLW 1990-09-07

NOVAPATH TSH ENZYME IMMUNOASSAY

Applicant Bio-Rad

K number K903311

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JLW 1990-07-10

IMX ULTRASENTITIVE HTSH

Applicant Abbott Mfg., Inc.

K number K902753

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JLW 1990-07-05

OPUS TSH TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K902333

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JLW 1990-04-11

ENZYMUN TEST(R) TSH-S

Applicant Boehringer Mannheim Corp.

K number K900277

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JLW 1990-03-09

AFFINITY(TM) HTSH(TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K897138

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JLW 1990-02-23

THYROID STIMULATING HORMONE-EIA-XT

Applicant In Vitro Diagnostics, Inc.

K number K896867

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JLW 1990-01-19

MILENIA (TM) TSH

Applicant Diagnostic Products Corp.

K number K900014

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JLW 1989-10-31

CYBERFLUOR FIAGEN TSH

Applicant Cyberfluor, Inc.

K number K895396

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JLW 1989-03-28

COTUBE(TM) TSH IRMA

Applicant Bio-Rad

K number K890802

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JLW 1989-03-16

TSH MICROASSAY

Applicant Diamedix Corp.

K number K890579

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JLW 1989-02-10

VENTREX COATED TUBE HIGH SENSITIVITY TSH

Applicant Ventrex Laboratories, Inc.

K number K885157

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JLW 1989-01-03

MODIFIED TSH IRMA KIT

Applicant Pacific Biotech, Inc.

K number K883742

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JLW 1988-12-15

THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL

Applicant Immuchem Corp.

K number K883726

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JLW 1988-10-03

DELFIA(TM) NEONATAL HTSH KIT

Applicant Pharmacia, Inc.

K number K881627

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JLW 1988-09-22

AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT

Applicant Amersham Corp.

K number K882907

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JLW 1988-09-13

VENTREX COATED TUBE TSH

Applicant Ventrex Laboratories, Inc.

K number K883342

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JLW 1988-07-21

REAGENTS FOR TSH ASSAY

Applicant Sclavo, Inc.

K number K881381

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JLW 1988-05-27

LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY

Applicant London Diagnostics, Inc.

K number K881443

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JLW 1988-04-05

ABBOTT IMX HTSH

Applicant Abbott Laboratories

K number K880086

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JLW 1987-12-18

FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301

Applicant Cyberfluor, Inc.

K number K874622

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JLW 1987-11-03

TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093

Applicant Medix Biotech, Inc.

K number K874061

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JLW 1987-10-02

BINAX L.S. TSH IRMA TEST KIT

Applicant Binax, Inc.

K number K873303

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JLW 1987-07-31

TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.

Applicant Serono Diagnostics, Inc.

K number K872897

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JLW 1987-07-01

IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX

Applicant Diagnostic Products Corp.

K number K872305

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JLW 1987-05-26

AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT

Applicant Micromedic Systems

K number K871505

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JLW 1987-05-26

MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT

Applicant Micromedic Systems

K number K870904

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JLW 1987-05-12

DELFIA (TM) HTSH KIT

Applicant Lkb Instruments, Inc.

K number K871644

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JLW 1987-04-01

AUTOPAK TSH MONOCLONAL IRMA KIT

Applicant Micromedic Systems

K number K870245

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JLW 1987-04-01

IQ TSH IMMUNOASSAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K870244

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JLW 1987-03-17

DACOMED PENILE PROSTHESIS SIZER

Applicant Dacomed Corp.

K number K870320

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JLW 1987-03-13

THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT

Applicant Immuchem Corp.

K number K865071

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JLW 1987-03-12

AFFINITY(TM) HTSH IMMUNIT(TM)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K865081

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JLW 1987-02-04

TSH MAB IRMA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K864839

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JLW 1987-02-04

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

Applicant Bio Mega Diagnostic, Inc.

K number K864659

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JLW 1987-01-07

TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP

Applicant Serono Diagnostics, Inc.

K number K864677

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JLW 1986-12-18

DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT

Applicant Diagnostic Systems Laboratories, Inc.

K number K864133

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JLW 1986-12-16

DSL-4800 ACTIVE TM TSH EIA SYSTEM

Applicant Diagnostic Systems Laboratories, Inc.

K number K864134

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JLW 1986-12-16

UBI MAGIWEL(TM) TSH QUANTITATIVE

Applicant United Biotech, Inc.

K number K864079

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JLW 1986-11-21

TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM

Applicant Hybritech, Inc.

K number K863859

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JLW 1986-08-29

CIBA CORNING MAGIC LITE TSH IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K862407

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JLW 1986-08-19

STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant American Dade

K number K862428

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JLW 1986-07-14

MICROMEDIC HTSH MONOCLONAL IRMA KIT

Applicant Micromedic Systems

K number K860813

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JLW 1986-07-02

V-TREND EIA TSH

Applicant V-Tech, Inc.

K number K861918

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JLW 1986-06-27

TSH IRMA KIT

Applicant Pacific Biotech, Inc.

K number K862249

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JLW 1986-06-19

TERUMO SENSIBEAD EIA TSH KIT

Applicant Terumo Medical Corp.

K number K861573

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JLW 1986-06-16

SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K861920

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JLW 1986-04-28

TSHK-NN RIA KIT

Applicant Cis-Us, Inc.

K number K860824

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JLW 1986-04-11

ECHOCLONAL HTSH IRMA

Applicant Bio-Rad

K number K860288

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JLW 1986-03-17

TSH-IRMA COAT-A-COUNT KIT

Applicant Diagnostic Products Corp.

K number K860054

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JLW 1986-01-07

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT

Applicant Bioclinical Systems, Inc.

K number K854379

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JLW 1985-10-25

NML TSH IRMA

Applicant Organon Teknika Corp.

K number K854087

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JLW 1985-10-22

BETA-TSH-IRMA

Applicant Leeco Diagnostics, Inc.

K number K853977

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JLW 1985-10-02

ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM

Applicant Nichols Institute Diagnostics

K number K853717

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JLW 1985-07-12

NML TSH IRMA

Applicant Nuclear Medical Laboratories, Inc.

K number K852438

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JLW 1985-07-09

LEE-BEAD TSH(EIA)

Applicant Lecco Diagnostics, Inc.

K number K852224

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JLW 1985-06-13

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA

Applicant Corning Medical & Scientific

K number K851329

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JLW 1985-05-31

ENDAB TSH

Applicant Immunotech Corp.

K number K851980

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JLW 1985-05-31

DELFIA HTSH KIT

Applicant Lkb Instruments, Inc.

K number K851120

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JLW 1985-04-29

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE

Applicant Euro-Diagnostics BV

K number K851148

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JLW 1985-03-05

TSH-STAT

Applicant Nuclear Medical Laboratories, Inc.

K number K844583

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JLW 1985-03-04

TERUMO SENSIBEAD EIA TSH KIT

Applicant Terumo Medical Corp.

K number K850376

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JLW 1984-11-02

ABBOTT HTSH EIA DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K843540

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JLW 1984-10-11

ENCORE TSH REAGENT

Applicant Hybritech, Inc.

K number K843395

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JLW 1984-10-02

TSH QUIK RIA KIT

Applicant Pacific Biotech, Inc.

K number K843545

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JLW 1984-09-26

ACCUSCREEN TSH

Applicant Neometrics, Inc.

K number K843281

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JLW 1984-09-12

SUCROSEP THYROID STIMULATING HORMONE

Applicant Boots-Celltech Diagnostics, Inc.

K number K842593

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JLW 1984-09-04

AMERLEX-M TSH RIA

Applicant Amersham Corp.

K number K842948

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JLW 1984-05-22

BLOOD SPOT NEONATAL TSH RADIOIMMUNO

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K841606

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JLW 1984-05-07

BIODEX ACT-O-KIT TSH-RIA-

Applicant Biodan Medical Systems, Ltd.

K number K840088

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JLW 1984-02-04

RADIOIMMUNOASSAY, THYROID STIMU. HORMONE

Applicant Biosan Laboratories, Inc.

K number K833193

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JLW 1983-12-29

SERUM THYROTROPIN ASSAY KIT, TIPSEP-

Applicant Nuclear Diagnostics, Inc.

K number K833713

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JLW 1983-10-31

TANDEM-E THYROID STIMULATING HORMONE KIT

Applicant Hybritech, Inc.

K number K832813

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JLW 1983-10-14

ENZYMUNE-TEST TSH

Applicant Icl Scientific

K number K832823

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JLW 1983-09-20

EPSILON TSH TEST KIT

Applicant Beckman Instruments, Inc.

K number K831972

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JLW 1983-09-12

PHASE II TSH KIT

Applicant Medical & Scientific Designs, Inc.

K number K832499

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JLW 1983-09-12

AUTOPAK NEONATAL TSH RIA KIT

Applicant Micromedic Systems

K number K832462

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JLW 1983-09-01

MAGIC TSH 125I RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K832313

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JLW 1983-04-28

VENTREX ENZYME TSH KIT

Applicant Ventrex Laboratories, Inc.

K number K830928

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JLW 1983-01-28

NEONATAL NTSH RADIOIMMUNOASSAY SYS

Applicant Corning Medical & Scientific

K number K830036

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JLW 1983-01-05

DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO

Applicant Corning Medical & Scientific

K number K823688

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JLW 1982-11-01

THYROID STIMULATING HORMONE

Applicant Pcl-Ria, Inc.

K number K822935

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JLW 1982-10-27

HISH EIA DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K822827

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JLW 1982-10-13

TAMDEM-R THYROID STIMULATING HORMONE KIT

Applicant Hybritech, Inc.

K number K822705

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JLW 1982-08-27

QUANTIMUNE HTSH IRMA

Applicant Bio-Rad

K number K822291

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JLW 1982-06-14

(125I) HTSH RADIOIMMUNOASSAY KIT

Applicant Yang Laboratories, Inc.

K number K821620

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JLW 1982-05-14

TSH-SQUIBB RADIOIMMUNOASSAY KIT

Applicant Squibb & Sons, Inc.

K number K821174

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JLW 1982-01-28

TSH (RIA) KIT

Applicant Immuno Assay Corp.

K number K820089

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JLW 1982-01-22

MICROMEDIC HTSH RIA KIT

Applicant Micromedic Systems

K number K813645

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JLW 1981-12-31

IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY

Applicant Micromedic Systems

K number K813525

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JLW 1981-12-22

RADIOIMMUNOASSAY FOR HUMAN THYROID

Applicant Leeco Diagnostics, Inc.

K number K813392

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JLW 1981-08-13

AMERLEX TSH RIA KIT

Applicant Amersham Corp.

K number K812136

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JLW 1981-06-18

TSH-P.E.G.

Applicant Nuclear Diagnostics, Inc.

K number K811558

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JLW 1981-06-09

TECHNICON STAR SYSTEM

Applicant Technicon Instruments Corp.

K number K811431

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JLW 1981-04-17

RADIOIMMUNOASSAY THYROID STIM. HORM. KIT

Applicant Endocrine-Metabolic Center

K number K810948

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JLW 1981-02-10

DAC-CEL TSH

Applicant Burroughs Wellcome Co.

K number K810213

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