JLW · Radioimmunoassay, Thyroid-Stimulating Hormone
Clinical Chemistry · 21 CFR 862.1690 · Class 2
Overview
| Product Code | JLW |
|---|---|
| Device Name | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Regulation | 21 CFR 862.1690 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Classification Rationale
Class II.
Cleared Devices (242)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | Feb 6, 2026 | SESE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | Apr 25, 2025 | SESE |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | Jul 22, 2024 | SESE |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | Apr 4, 2024 | SESE |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | Jul 13, 2023 | SESE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | Nov 10, 2022 | SESE |
| K190773 | Elecsys TSH | Roche Diagnostics | Apr 16, 2019 | SESE |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | Oct 13, 2017 | SESE |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | Jul 28, 2017 | SESE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Jul 14, 2017 | SESE |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | Jan 23, 2017 | SESE |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | Sysmex America, Inc. | Oct 21, 2016 | SESE |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | Aug 18, 2016 | SESE |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | May 31, 2016 | SESE |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics, Inc. | Nov 20, 2015 | SESE |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | May 1, 2015 | SESE |
| K141999 | ADVIA CENTAUR TSH | Siemens Healthcare Diagnostics, Inc. | Apr 22, 2015 | SESE |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | Mar 14, 2014 | SESE |
| K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | Apr 5, 2013 | SESE |
| K110761 | MICT TSH | Magnabiosciences, LLC | Mar 9, 2012 | SESE |
| K101390 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | Aug 13, 2010 | SESE |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | Perkinelmer, Inc. | Sep 3, 2009 | SESE |
| K083844 | ADVIA CENTAUR TSH3-ULTRA METHOD | Siemens Healthcare Diagnostics | May 8, 2009 | SESE |
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | Ortho-Clinical Diagnostics | Dec 22, 2008 | SESE |
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM | Ortho-Clinical Diagnostics, Inc. | Oct 23, 2008 | SESE |
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 | Siemens Healthcare Diagnostics, Inc. | May 23, 2008 | SESE |
| K072458 | GBI TSH NEONATAL SCREENING KIT | Golden Bridge International, Inc. | Apr 10, 2008 | SESE |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | Monobind, Inc. | Apr 4, 2008 | SESE |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Olympus America, Inc. | Nov 29, 2006 | SESE |
| K060090 | DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Feb 27, 2006 | SESE |
| K052301 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | Jan 4, 2006 | SESE |
| K042281 | MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | Sep 16, 2004 | SESE |
| K041014 | TSH-CTK-3 IRMA | DiaSorin, Inc. | Jul 14, 2004 | SESE |
| K030912 | THYRO TEST | Thryotec | Jul 25, 2003 | SESE |
| K023093 | ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | Nov 25, 2002 | SESE |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Awareness Technology, Inc. | Jul 19, 2002 | SESE |
| K011527 | PRAXSYS RELIA TSH TEST | Praxsys Biosystems, Inc. | Aug 7, 2001 | SESE |
| K011525 | SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) | Biosafe Laboratories, Inc. | Jul 16, 2001 | SESE |
| K003752 | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) | Biosafe Laboratories, Inc. | Mar 23, 2001 | SESE |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | Neometrics, Inc. | Nov 2, 2000 | SESE |
| K001606 | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) | Repromedix Corp. | Oct 5, 2000 | SESE |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | Biocheck, Inc. | Jun 22, 1999 | SESE |
| K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | Biocheck, Inc. | Jun 22, 1999 | SESE |
| K990658 | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY | Little Nell Labs, Inc. | Jun 2, 1999 | SESE |
| K983442 | ABBOTT ARCHITECT TSH | Abbott Laboratories | Nov 20, 1998 | SESE |
| K981312 | 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Jun 5, 1998 | SESE |
| K981060 | ABBOTT AXSYM 3RD GENERATION TSH ASSAY | Abbott Laboratories | Apr 29, 1998 | SESE |
| K980574 | AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 | Alfa Biotech (Uk) , Ltd. | Mar 24, 1998 | SESE |
| K973276 | AUTODELFIA NEONATAL HTSH L KIT (B077-112) | Eg &G Wallac | Nov 20, 1997 | SESE |
| K972586 | AIA-PACK TSH 3RD-GEN ASSAY | Tosoh Medics, Inc. | Aug 29, 1997 | SESE |
| K971780 | THYROTROPIN(TSH) ELISA | Monobind | Jun 24, 1997 | SESE |
| K970393 | THYROID STIMULATING HORMONE METHOD | Dade Chemistry Systems, Inc. | Mar 3, 1997 | SESE |
| K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) | Johnson & Johnson Clinical Diagnostics, Inc. | Dec 16, 1996 | SESE |
| K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS | Biocircuits Corp. | Nov 18, 1996 | SESE |
| K962464 | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) | Scantibodies Laboratory, Inc. | Oct 8, 1996 | SESE |
| K962216 | TSH (MICROWELL) ELISA | Biomerica, Inc. | Sep 19, 1996 | SESE |
| K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | Teco Diagnostics | Sep 11, 1996 | SESE |
| K961491 | ELECSYS TSH ASSAY | Boehringer Mannheim Corp. | Jul 22, 1996 | SESE |
| K961650 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT | Nichols Institute Diagnostics | Jul 16, 1996 | SESE |
| K960195 | THYROCHEK ONE-STEP RAPID TSH ASSAY | Franklin Diagnostics, Inc. | Apr 15, 1996 | SESE |
| K954825 | ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Bio-Rad Laboratories, Inc. | Nov 21, 1995 | SESE |
| K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 14, 1995 | SESE |
| K952148 | AXSYM ULTRASENSITIVE HTSH II | Abbott Laboratories | Jun 29, 1995 | SESE |
| K951796 | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jun 13, 1995 | SESE |
| K950921 | CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY | Nichols Institute Diagnostics | May 2, 1995 | SESE |
| K943195 | COAT-A-COUNT NEONATAL TSH IRMA | Diagnostic Products Corp. | Mar 13, 1995 | SESE |
| K942658 | NEOSCREEN ELISA TSH | Pantex, Div. Bio-Analysis, Inc. | Feb 24, 1995 | SESE |
| K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT | Sealite Sciences, Inc. | Jan 17, 1995 | SESE |
| K940006 | IMMULITE THIRD GENERATION (MODIFICATION) | Diagnostic Products Corp. | Dec 19, 1994 | SESE |
| K935399 | RADIAS NEONATAL TSH ENZYME IMMUNOASSAY | Bio-Rad | Dec 19, 1994 | SESE |
| K933212 | IMMULITE RAPID TSH | Diagnostic Products Corp. | Dec 19, 1994 | SESE |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Dupont Medical Products | Oct 3, 1994 | SESE |
| K935049 | ELEGANCE NEONATAL TSH ELISA | Bioclone Australia Pty , Ltd. | Oct 3, 1994 | SESE |
| K942566 | IMX ULTRASENSISTIVE HTSH II | Abbott Laboratories | Aug 16, 1994 | SESE |
| K934410 | AXSYM ULTRASENSITIVE HTSH | Abbott Laboratories | Jun 21, 1994 | SESE |
| K935119 | RADIAS 3RD GENERATION TSH IMMUNOASSAY | Bio-Rad | Apr 6, 1994 | SESE |
| K930776 | COBAS CORE TSH EIA | Roche Diagnostic Systems, Inc. | Dec 3, 1993 | SESE |
| K930006 | AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT | Bio-Chem Laboratory Systems, Inc. | Sep 9, 1993 | SESE |
| K930050 | SIA THYROID STIMULATING HORMONE ELISA KIT | Sigma Chemical Co. | Aug 19, 1993 | SESE |
| K931061 | RADIAS TSH ENZYME IMMUNOASSAY | Bio-Rad | Jun 16, 1993 | SESE |
| K923532 | NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY | Solarcare Technologies Corp,Inc. | Mar 12, 1993 | SESE |
| K925637 | ACCESS HTSH ASSAY | Bio-Rad Laboratories, Inc. | Mar 1, 1993 | SESE |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Becton Dickinson Advanced Diagnostics | Dec 28, 1992 | SESE |
| K923401 | DELFIA HTSH ULTRA KIT | Wallac OY | Nov 30, 1992 | SESE |
| K922701 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD | E.I. Dupont DE Nemours & Co., Inc. | Sep 9, 1992 | SESE |
| K922138 | VISTA ULTRASENSITIVE HTSH ASSAY | Syva Co. | Jul 21, 1992 | SESE |
| K922736 | KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA | Eastman Kodak Company | Jul 10, 1992 | SESE |
| K921958 | ELISA TUBE TSH TEST | Bio Clinic Co. | Jul 2, 1992 | SESE |
| K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 | Medix Biotech, Inc. | Jun 29, 1992 | SESE |
| K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY | Biomerieux Vitek, Inc. | Jun 18, 1992 | SESE |
| K920856 | VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS | Hycor Biomedical, Inc. | Mar 26, 1992 | SESE |
| K920442 | IMMUCHEM TSH-MW ELISA | Icn Biomedicals, Inc. | Mar 18, 1992 | SESE |
| K915195 | ENZYMUN-TEST TSH | Boehringer Mannheim Corp. | Feb 14, 1992 | SESE |
| K914756 | ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT | Medix Biotech, Inc. | Jan 15, 1992 | SESE |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | Icn Biomedicals, Inc. | Dec 13, 1991 | SESE |
| K912852 | STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO | Baxter Healthcare Corp | Sep 27, 1991 | SESE |
| K912583 | MAGIC LITE TSH (HS) IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Aug 12, 1991 | SESE |
| K912324 | NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 20, 1991 | SESE |
| K912241 | STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | Jun 20, 1991 | SESE |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | May 24, 1991 | SESE |
| K910981 | CIBA CORNING ACS TSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Apr 30, 1991 | SESE |
| K910411 | MICROZYME TSH ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Apr 3, 1991 | SESE |
| K910256 | ECLIPSE ICA TSH | Biotope, Inc. | Feb 22, 1991 | SESE |
| K905710 | PHARMACIA DELFIA NEONATAL HTSH KIT | Pharmacia, Inc. | Feb 21, 1991 | SESE |
| K905769 | IMMULITE HS-TSH | Cirrus Diagnostics, Inc. | Jan 31, 1991 | SESE |
| K905099 | ELEGANCE TSH ELISA | Bioclone Australia Pty , Ltd. | Dec 18, 1990 | SESE |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | Amersham Corp. | Nov 2, 1990 | SESE |
| K903725 | EZ-BEAD TSH ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Oct 26, 1990 | SESE |
| K903391 | ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM | Nichols Institute | Oct 12, 1990 | SESE |
| K903311 | NOVAPATH TSH ENZYME IMMUNOASSAY | Bio-Rad | Sep 7, 1990 | SESE |
| K902753 | IMX ULTRASENTITIVE HTSH | Abbott Mfg., Inc. | Jul 10, 1990 | SESE |
| K902333 | OPUS TSH TEST SYSTEM | Pb Diagnostic Systems, Inc. | Jul 5, 1990 | SESE |
| K900277 | ENZYMUN TEST(R) TSH-S | Boehringer Mannheim Corp. | Apr 11, 1990 | SESE |
| K897138 | AFFINITY(TM) HTSH(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 9, 1990 | SESE |
| K896867 | THYROID STIMULATING HORMONE-EIA-XT | In Vitro Diagnostics, Inc. | Feb 23, 1990 | SESE |
| K900014 | MILENIA (TM) TSH | Diagnostic Products Corp. | Jan 19, 1990 | SESE |
| K895396 | CYBERFLUOR FIAGEN TSH | Cyberfluor, Inc. | Oct 31, 1989 | SESE |
| K890802 | COTUBE(TM) TSH IRMA | Bio-Rad | Mar 28, 1989 | SESE |
| K890579 | TSH MICROASSAY | Diamedix Corp. | Mar 16, 1989 | SESE |
| K885157 | VENTREX COATED TUBE HIGH SENSITIVITY TSH | Ventrex Laboratories, Inc. | Feb 10, 1989 | SESE |
| K883742 | MODIFIED TSH IRMA KIT | Pacific Biotech, Inc. | Jan 3, 1989 | SESE |
| K883726 | THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL | Immuchem Corp. | Dec 15, 1988 | SESE |
| K881627 | DELFIA(TM) NEONATAL HTSH KIT | Pharmacia, Inc. | Oct 3, 1988 | SESE |
| K882907 | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT | Amersham Corp. | Sep 22, 1988 | SESE |
| K883342 | VENTREX COATED TUBE TSH | Ventrex Laboratories, Inc. | Sep 13, 1988 | SESE |
| K881381 | REAGENTS FOR TSH ASSAY | Sclavo, Inc. | Jul 21, 1988 | SESE |
| K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY | London Diagnostics, Inc. | May 27, 1988 | SESE |
| K880086 | ABBOTT IMX HTSH | Abbott Laboratories | Apr 5, 1988 | SESE |
| K874622 | FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 | Cyberfluor, Inc. | Dec 18, 1987 | SESE |
| K874061 | TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 | Medix Biotech, Inc. | Nov 3, 1987 | SESE |
| K873303 | BINAX L.S. TSH IRMA TEST KIT | Binax, Inc. | Oct 2, 1987 | SESE |
| K872897 | TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. | Serono Diagnostics, Inc. | Jul 31, 1987 | SESE |
| K872305 | IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX | Diagnostic Products Corp. | Jul 1, 1987 | SESE |
| K871505 | AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT | Micromedic Systems | May 26, 1987 | SESE |
| K870904 | MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT | Micromedic Systems | May 26, 1987 | SESE |
| K871644 | DELFIA (TM) HTSH KIT | Lkb Instruments, Inc. | May 12, 1987 | SESE |
| K870245 | AUTOPAK TSH MONOCLONAL IRMA KIT | Micromedic Systems | Apr 1, 1987 | SESE |
| K870244 | IQ TSH IMMUNOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | Apr 1, 1987 | SESE |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | Dacomed Corp. | Mar 17, 1987 | SESE |
| K865071 | THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT | Immuchem Corp. | Mar 13, 1987 | SESE |
| K865081 | AFFINITY(TM) HTSH IMMUNIT(TM) | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 12, 1987 | SESE |
| K864839 | TSH MAB IRMA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 4, 1987 | SESE |
| K864659 | BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH | Bio Mega Diagnostic, Inc. | Feb 4, 1987 | SESE |
| K864677 | TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP | Serono Diagnostics, Inc. | Jan 7, 1987 | SESE |
| K864133 | DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT | Diagnostic Systems Laboratories, Inc. | Dec 18, 1986 | SESE |
| K864134 | DSL-4800 ACTIVE TM TSH EIA SYSTEM | Diagnostic Systems Laboratories, Inc. | Dec 16, 1986 | SESE |
| K864079 | UBI MAGIWEL(TM) TSH QUANTITATIVE | United Biotech, Inc. | Dec 16, 1986 | SESE |
| K863859 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM | Hybritech, Inc. | Nov 21, 1986 | SESE |
| K862407 | CIBA CORNING MAGIC LITE TSH IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Aug 29, 1986 | SESE |
| K862428 | STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | Aug 19, 1986 | SESE |
| K860813 | MICROMEDIC HTSH MONOCLONAL IRMA KIT | Micromedic Systems | Jul 14, 1986 | SESE |
| K861918 | V-TREND EIA TSH | V-Tech, Inc. | Jul 2, 1986 | SESE |
| K862249 | TSH IRMA KIT | Pacific Biotech, Inc. | Jun 27, 1986 | SESE |
| K861573 | TERUMO SENSIBEAD EIA TSH KIT | Terumo Medical Corp. | Jun 19, 1986 | SESE |
| K861920 | SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 16, 1986 | SESE |
| K860824 | TSHK-NN RIA KIT | Cis-Us, Inc. | Apr 28, 1986 | SESE |
| K860288 | ECHOCLONAL HTSH IRMA | Bio-Rad | Apr 11, 1986 | SESE |
| K860054 | TSH-IRMA COAT-A-COUNT KIT | Diagnostic Products Corp. | Mar 17, 1986 | SESE |
| K854379 | MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT | Bioclinical Systems, Inc. | Jan 7, 1986 | SESE |
| K854087 | NML TSH IRMA | Organon Teknika Corp. | Oct 25, 1985 | SESE |
| K853977 | BETA-TSH-IRMA | Leeco Diagnostics, Inc. | Oct 22, 1985 | SESE |
| K853717 | ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | Oct 2, 1985 | SESE |
| K852438 | NML TSH IRMA | Nuclear Medical Laboratories, Inc. | Jul 12, 1985 | SESE |
| K852224 | LEE-BEAD TSH(EIA) | Lecco Diagnostics, Inc. | Jul 9, 1985 | SESE |
| K851329 | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA | Corning Medical & Scientific | Jun 13, 1985 | SESE |
| K851980 | ENDAB TSH | Immunotech Corp. | May 31, 1985 | SESE |
| K851120 | DELFIA HTSH KIT | Lkb Instruments, Inc. | May 31, 1985 | SESE |
| K851148 | TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE | Euro-Diagnostics BV | Apr 29, 1985 | SESE |
| K844583 | TSH-STAT | Nuclear Medical Laboratories, Inc. | Mar 5, 1985 | SESE |
| K850376 | TERUMO SENSIBEAD EIA TSH KIT | Terumo Medical Corp. | Mar 4, 1985 | SESE |
| K843540 | ABBOTT HTSH EIA DIAGNOSTIC KIT | Abbott Laboratories | Nov 2, 1984 | SESE |
| K843395 | ENCORE TSH REAGENT | Hybritech, Inc. | Oct 11, 1984 | SESE |
| K843545 | TSH QUIK RIA KIT | Pacific Biotech, Inc. | Oct 2, 1984 | SESE |
| K843281 | ACCUSCREEN TSH | Neometrics, Inc. | Sep 26, 1984 | SESE |
| K842593 | SUCROSEP THYROID STIMULATING HORMONE | Boots-Celltech Diagnostics, Inc. | Sep 12, 1984 | SESE |
| K842948 | AMERLEX-M TSH RIA | Amersham Corp. | Sep 4, 1984 | SESE |
| K841606 | BLOOD SPOT NEONATAL TSH RADIOIMMUNO | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 22, 1984 | SESE |
| K840088 | BIODEX ACT-O-KIT TSH-RIA- | Biodan Medical Systems, Ltd. | May 7, 1984 | SESE |
| K833193 | RADIOIMMUNOASSAY, THYROID STIMU. HORMONE | Biosan Laboratories, Inc. | Feb 4, 1984 | SESE |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Nuclear Diagnostics, Inc. | Dec 29, 1983 | SESE |
| K832813 | TANDEM-E THYROID STIMULATING HORMONE KIT | Hybritech, Inc. | Oct 31, 1983 | SESE |
| K832823 | ENZYMUNE-TEST TSH | Icl Scientific | Oct 14, 1983 | SESE |
| K831972 | EPSILON TSH TEST KIT | Beckman Instruments, Inc. | Sep 20, 1983 | SESE |
| K832499 | PHASE II TSH KIT | Medical & Scientific Designs, Inc. | Sep 12, 1983 | SESE |
| K832462 | AUTOPAK NEONATAL TSH RIA KIT | Micromedic Systems | Sep 12, 1983 | SESE |
| K832313 | MAGIC TSH 125I RADIOIMMUNOASSAY | Corning Medical & Scientific | Sep 1, 1983 | SESE |
| K830928 | VENTREX ENZYME TSH KIT | Ventrex Laboratories, Inc. | Apr 28, 1983 | SESE |
| K830036 | NEONATAL NTSH RADIOIMMUNOASSAY SYS | Corning Medical & Scientific | Jan 28, 1983 | SESE |
| K823688 | DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO | Corning Medical & Scientific | Jan 5, 1983 | SESE |
| K822935 | THYROID STIMULATING HORMONE | Pcl-Ria, Inc. | Nov 1, 1982 | SESE |
| K822827 | HISH EIA DIAGNOSTIC KIT | Abbott Laboratories | Oct 27, 1982 | SESE |
| K822705 | TAMDEM-R THYROID STIMULATING HORMONE KIT | Hybritech, Inc. | Oct 13, 1982 | SESE |
| K822291 | QUANTIMUNE HTSH IRMA | Bio-Rad | Aug 27, 1982 | SESE |
| K821620 | (125I) HTSH RADIOIMMUNOASSAY KIT | Yang Laboratories, Inc. | Jun 14, 1982 | SESE |
| K821174 | TSH-SQUIBB RADIOIMMUNOASSAY KIT | Squibb & Sons, Inc. | May 14, 1982 | SESE |
| K820089 | TSH (RIA) KIT | Immuno Assay Corp. | Jan 28, 1982 | SESE |
| K813645 | MICROMEDIC HTSH RIA KIT | Micromedic Systems | Jan 22, 1982 | SESE |
| K813525 | IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY | Micromedic Systems | Dec 31, 1981 | SESE |
| K813392 | RADIOIMMUNOASSAY FOR HUMAN THYROID | Leeco Diagnostics, Inc. | Dec 22, 1981 | SESE |
| K812136 | AMERLEX TSH RIA KIT | Amersham Corp. | Aug 13, 1981 | SESE |
Top Applicants
- Abbott Laboratories — 10 clearances
- Bio-Rad — 9 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 9 clearances
- Siemens Healthcare Diagnostics, Inc. — 8 clearances
- Micromedic Systems — 8 clearances
