| Atellica® IM TSH3-Ultra II (TSH3ULII) (K251543) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 |
| Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) (K243570) | Siemens Healthcare Diagnostics | 2025-04-25 |
| Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (K234091) | Genalyte, Inc. | 2024-07-22 |
| ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (K233050) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 |
| Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (K222116) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 |
| Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (K221225) | Beckman Coulter, Inc. | 2022-11-10 |
| Elecsys TSH (K190773) | Roche Diagnostics | 2019-04-16 |
| AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (K170232) | Boditech Med, Inc. | 2017-10-13 |
| Lumipulse G TSH-III Immunoreaction Cartridges (K171103) | Fujirebio Diagnostics,Inc. | 2017-07-28 |
| MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (K162698) | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 |
| Elecsys TSH assay, cobas e 801 Immunoassay analyzer (K162606) | Roche Diagnostics | 2017-01-23 |
| Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control (K160541) | Sysmex America, Inc. | 2016-10-21 |
| Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems (K153651) | Beckman Coulter, Inc. | 2016-08-18 |
| IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (K160647) | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 |
| Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (K151792) | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 |
| ADVIA Centaur TSH3-Ultra (K150403) | Siemens Healthcare Diagnostics, Inc. | 2015-05-01 |
| ADVIA CENTAUR TSH (K141999) | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 |
| FREND TSH (REAGENT CARTRIDGE) (K131928) | Nanoentek USA, Inc. | 2014-03-14 |
| LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 (K130469) | DiaSorin, Inc. | 2013-04-05 |
| MICT TSH (K110761) | Magnabiosciences, LLC | 2012-03-09 |
| FASTPACK TSH IMMUNOASSAY (K101390) | Qualigen, Inc. | 2010-08-13 |
| GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) | Perkinelmer, Inc. | 2009-09-03 |
| ADVIA CENTAUR TSH3-ULTRA METHOD (K083844) | Siemens Healthcare Diagnostics | 2009-05-08 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM (K083173) | Ortho-Clinical Diagnostics | 2008-12-22 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM (K081543) | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 |
| DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 (K081074) | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 |
| GBI TSH NEONATAL SCREENING KIT (K072458) | Golden Bridge International, Inc. | 2008-04-10 |
| ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (K063437) | Monobind, Inc. | 2008-04-04 |
| OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM (K062581) | Olympus America, Inc. | 2006-11-29 |
| DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE (K060090) | Dade Behring, Inc. | 2006-02-27 |
| FASTPACK TSH IMMUNOASSAY (K052301) | Qualigen, Inc. | 2006-01-04 |
| MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY (K042281) | Beckman Coulter, Inc. | 2004-09-16 |
| TSH-CTK-3 IRMA (K041014) | DiaSorin, Inc. | 2004-07-14 |
| THYRO TEST (K030912) | Thryotec | 2003-07-25 |
| ACCESS HYPERSENSITIVE HTSH ASSAY (K023093) | Beckman Coulter, Inc. | 2002-11-25 |
| CHEMWELL, ALSO KNOWN AS PROJECT 2900 (K013420) | Awareness Technology, Inc. | 2002-07-19 |
| PRAXSYS RELIA TSH TEST (K011527) | Praxsys Biosystems, Inc. | 2001-08-07 |
| SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) (K011525) | Biosafe Laboratories, Inc. | 2001-07-16 |
| BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) (K003752) | Biosafe Laboratories, Inc. | 2001-03-23 |
| ACCUWELL TSH, MODEL KAW-TSH-960 (K001455) | Neometrics, Inc. | 2000-11-02 |
| REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) (K001606) | Repromedix Corp. | 2000-10-05 |
| TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 (K991146) | Biocheck, Inc. | 1999-06-22 |
| BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 (K990993) | Biocheck, Inc. | 1999-06-22 |
| THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY (K990658) | Little Nell Labs, Inc. | 1999-06-02 |
| ABBOTT ARCHITECT TSH (K983442) | Abbott Laboratories | 1998-11-20 |
| 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K981312) | Bayer Corp. | 1998-06-05 |
| ABBOTT AXSYM 3RD GENERATION TSH ASSAY (K981060) | Abbott Laboratories | 1998-04-29 |
| AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 (K980574) | Alfa Biotech (Uk) , Ltd. | 1998-03-24 |
| AUTODELFIA NEONATAL HTSH L KIT (B077-112) (K973276) | Eg &G Wallac | 1997-11-20 |
| AIA-PACK TSH 3RD-GEN ASSAY (K972586) | Tosoh Medics, Inc. | 1997-08-29 |
| THYROTROPIN(TSH) ELISA (K971780) | Monobind | 1997-06-24 |
| THYROID STIMULATING HORMONE METHOD (K970393) | Dade Chemistry Systems, Inc. | 1997-03-03 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) (K964558) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-16 |
| BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS (K961566) | Biocircuits Corp. | 1996-11-18 |
| SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) (K962464) | Scantibodies Laboratory, Inc. | 1996-10-08 |
| TSH (MICROWELL) ELISA (K962216) | Biomerica, Inc. | 1996-09-19 |
| THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST (K961629) | Teco Diagnostics | 1996-09-11 |
| ELECSYS TSH ASSAY (K961491) | Boehringer Mannheim Corp. | 1996-07-22 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT (K961650) | Nichols Institute Diagnostics | 1996-07-16 |
| THYROCHEK ONE-STEP RAPID TSH ASSAY (K960195) | Franklin Diagnostics, Inc. | 1996-04-15 |
| ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K954825) | Bio-Rad Laboratories, Inc. | 1995-11-21 |
| AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) (K952211) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-14 |
| AXSYM ULTRASENSITIVE HTSH II (K952148) | Abbott Laboratories | 1995-06-29 |
| CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY (K951796) | Ciba Corning Diagnostics Corp. | 1995-06-13 |
| CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY (K950921) | Nichols Institute Diagnostics | 1995-05-02 |
| COAT-A-COUNT NEONATAL TSH IRMA (K943195) | Diagnostic Products Corp. | 1995-03-13 |
| NEOSCREEN ELISA TSH (K942658) | Pantex, Div. Bio-Analysis, Inc. | 1995-02-24 |
| AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (K942661) | Sealite Sciences, Inc. | 1995-01-17 |
| IMMULITE RAPID TSH (K933212) | Diagnostic Products Corp. | 1994-12-19 |
| RADIAS NEONATAL TSH ENZYME IMMUNOASSAY (K935399) | Bio-Rad | 1994-12-19 |
| IMMULITE THIRD GENERATION (MODIFICATION) (K940006) | Diagnostic Products Corp. | 1994-12-19 |
| ELEGANCE NEONATAL TSH ELISA (K935049) | Bioclone Australia Pty , Ltd. | 1994-10-03 |
| DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (K941146) | Dupont Medical Products | 1994-10-03 |
| IMX ULTRASENSISTIVE HTSH II (K942566) | Abbott Laboratories | 1994-08-16 |
| AXSYM ULTRASENSITIVE HTSH (K934410) | Abbott Laboratories | 1994-06-21 |
| RADIAS 3RD GENERATION TSH IMMUNOASSAY (K935119) | Bio-Rad | 1994-04-06 |
| COBAS CORE TSH EIA (K930776) | Roche Diagnostic Systems, Inc. | 1993-12-03 |
| AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (K930006) | Bio-Chem Laboratory Systems, Inc. | 1993-09-09 |
| SIA THYROID STIMULATING HORMONE ELISA KIT (K930050) | Sigma Chemical Co. | 1993-08-19 |
| RADIAS TSH ENZYME IMMUNOASSAY (K931061) | Bio-Rad | 1993-06-16 |
| NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY (K923532) | Solarcare Technologies Corp,Inc. | 1993-03-12 |
| ACCESS HTSH ASSAY (K925637) | Bio-Rad Laboratories, Inc. | 1993-03-01 |
| BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE (K925132) | Becton Dickinson Advanced Diagnostics | 1992-12-28 |
| DELFIA HTSH ULTRA KIT (K923401) | Wallac OY | 1992-11-30 |
| DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD (K922701) | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-09 |
| VISTA ULTRASENSITIVE HTSH ASSAY (K922138) | Syva Co. | 1992-07-21 |
| KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA (K922736) | Eastman Kodak Company | 1992-07-10 |
| ELISA TUBE TSH TEST (K921958) | Bio Clinic Co. | 1992-07-02 |
| TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (K921700) | Medix Biotech, Inc. | 1992-06-29 |
| VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY (K921816) | Biomerieux Vitek, Inc. | 1992-06-18 |
| VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS (K920856) | Hycor Biomedical, Inc. | 1992-03-26 |
| IMMUCHEM TSH-MW ELISA (K920442) | Icn Biomedicals, Inc. | 1992-03-18 |
| ENZYMUN-TEST TSH (K915195) | Boehringer Mannheim Corp. | 1992-02-14 |
| ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT (K914756) | Medix Biotech, Inc. | 1992-01-15 |
| IMMUCHEM NEONATAL TSH-MP ELISA (K913963) | Icn Biomedicals, Inc. | 1991-12-13 |
| STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO (K912852) | Baxter Healthcare Corp | 1991-09-27 |
| MAGIC LITE TSH (HS) IMMUNOASSAY (K912583) | Ciba Corning Diagnostics Corp. | 1991-08-12 |
| STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY (K912241) | Baxter Healthcare Corp | 1991-06-20 |
| NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY (K912324) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-20 |
| SRI TSH IMMUNENZYMETRIC ASSAY (K910837) | Serono-Baker Diagnostics, Inc. | 1991-05-24 |