FDA Product Code
FDA Product Code JLW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1690
510(k) Clearances — 242 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2026-02-06 | Traditional | PDF ↗ |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | 2025-04-25 | Traditional | PDF ↗ |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | 2024-07-22 | Traditional | PDF ↗ |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | 2024-04-04 | Traditional | PDF ↗ |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | 2022-11-10 | Traditional | PDF ↗ |
| K190773 | Elecsys TSH | Roche Diagnostics | 2019-04-16 | Traditional | PDF ↗ |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | 2017-10-13 | Traditional | PDF ↗ |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2017-07-14 | Traditional | PDF ↗ |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | 2017-01-23 | Traditional | PDF ↗ |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | Sysmex America, Inc. | 2016-10-21 | Traditional | PDF ↗ |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2016-08-18 | Traditional | PDF ↗ |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | 2016-05-31 | Traditional | PDF ↗ |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | 2015-05-01 | Traditional | PDF ↗ |
| K141999 | ADVIA CENTAUR TSH | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 | Special | PDF ↗ |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | 2014-03-14 | Traditional | PDF ↗ |
| K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | 2013-04-05 | Traditional | PDF ↗ |
| K110761 | MICT TSH | Magnabiosciences, LLC | 2012-03-09 | Traditional | PDF ↗ |
| K101390 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | 2010-08-13 | Special | PDF ↗ |
| K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | Perkinelmer, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K083844 | ADVIA CENTAUR TSH3-ULTRA METHOD | Siemens Healthcare Diagnostics | 2009-05-08 | Traditional | PDF ↗ |
| K083173 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM | Ortho-Clinical Diagnostics | 2008-12-22 | Special | PDF ↗ |
| K081543 | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2008-10-23 | Special | PDF ↗ |
| K081074 | DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 | Siemens Healthcare Diagnostics, Inc. | 2008-05-23 | Special | PDF ↗ |
| K072458 | GBI TSH NEONATAL SCREENING KIT | Golden Bridge International, Inc. | 2008-04-10 | Traditional | PDF ↗ |
| K063437 | ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 | Monobind, Inc. | 2008-04-04 | Traditional | PDF ↗ |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Olympus America, Inc. | 2006-11-29 | Traditional | PDF ↗ |
| K060090 | DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-02-27 | Traditional | PDF ↗ |
| K052301 | FASTPACK TSH IMMUNOASSAY | Qualigen, Inc. | 2006-01-04 | Traditional | PDF ↗ |
| K042281 | MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | 2004-09-16 | Special | PDF ↗ |
| K041014 | TSH-CTK-3 IRMA | DiaSorin, Inc. | 2004-07-14 | Traditional | PDF ↗ |
| K030912 | THYRO TEST | Thryotec | 2003-07-25 | Traditional | PDF ↗ |
| K023093 | ACCESS HYPERSENSITIVE HTSH ASSAY | Beckman Coulter, Inc. | 2002-11-25 | Traditional | PDF ↗ |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Awareness Technology, Inc. | 2002-07-19 | Abbreviated | PDF ↗ |
| K011527 | PRAXSYS RELIA TSH TEST | Praxsys Biosystems, Inc. | 2001-08-07 | Traditional | PDF ↗ |
| K011525 | SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) | Biosafe Laboratories, Inc. | 2001-07-16 | Traditional | PDF ↗ |
| K003752 | BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) | Biosafe Laboratories, Inc. | 2001-03-23 | Traditional | PDF ↗ |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | Neometrics, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K001606 | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) | Repromedix Corp. | 2000-10-05 | Traditional | PDF ↗ |
| K991146 | TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 | Biocheck, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K990993 | BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 | Biocheck, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K990658 | THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY | Little Nell Labs, Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K983442 | ABBOTT ARCHITECT TSH | Abbott Laboratories | 1998-11-20 | Traditional | PDF ↗ |
| K981312 | 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1998-06-05 | Traditional | PDF ↗ |
| K981060 | ABBOTT AXSYM 3RD GENERATION TSH ASSAY | Abbott Laboratories | 1998-04-29 | Traditional | PDF ↗ |
| 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. | 1998-03-24 | Traditional | PDF ↗ |
| K973276 | AUTODELFIA NEONATAL HTSH L KIT (B077-112) | Eg &G Wallac | 1997-11-20 | Traditional | PDF ↗ |
| K972586 | AIA-PACK TSH 3RD-GEN ASSAY | Tosoh Medics, Inc. | 1997-08-29 | Traditional | PDF ↗ |
| K971780 | THYROTROPIN(TSH) ELISA | Monobind | 1997-06-24 | Traditional | PDF ↗ |
| K970393 | THYROID STIMULATING HORMONE METHOD | Dade Chemistry Systems, Inc. | 1997-03-03 | Traditional | PDF ↗ |
| K964558 | VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K961566 | BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS | Biocircuits Corp. | 1996-11-18 | Traditional | PDF ↗ |
| K962464 | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) | Scantibodies Laboratory, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K962216 | TSH (MICROWELL) ELISA | Biomerica, Inc. | 1996-09-19 | Traditional | PDF ↗ |
| K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | Teco Diagnostics | 1996-09-11 | Traditional | PDF ↗ |
| K961491 | ELECSYS TSH ASSAY | Boehringer Mannheim Corp. | 1996-07-22 | Traditional | PDF ↗ |
| K961650 | NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT | Nichols Institute Diagnostics | 1996-07-16 | Traditional | PDF ↗ |
| K960195 | THYROCHEK ONE-STEP RAPID TSH ASSAY | Franklin Diagnostics, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K954825 | ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Bio-Rad Laboratories, Inc. | 1995-11-21 | Traditional | PDF ↗ |
| K952211 | AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K952148 | AXSYM ULTRASENSITIVE HTSH II | Abbott Laboratories | 1995-06-29 | Traditional | PDF ↗ |
| K951796 | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-13 | Traditional | PDF ↗ |
| K950921 | CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY | Nichols Institute Diagnostics | 1995-05-02 | Traditional | PDF ↗ |
| K943195 | COAT-A-COUNT NEONATAL TSH IRMA | Diagnostic Products Corp. | 1995-03-13 | Traditional | PDF ↗ |
| K942658 | NEOSCREEN ELISA TSH | Pantex, Div. Bio-Analysis, Inc. | 1995-02-24 | Traditional | PDF ↗ |
| K942661 | AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT | Sealite Sciences, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K935399 | RADIAS NEONATAL TSH ENZYME IMMUNOASSAY | Bio-Rad | 1994-12-19 | Traditional | PDF ↗ |
| K933212 | IMMULITE RAPID TSH | Diagnostic Products Corp. | 1994-12-19 | Traditional | PDF ↗ |
| K940006 | IMMULITE THIRD GENERATION (MODIFICATION) | Diagnostic Products Corp. | 1994-12-19 | Traditional | PDF ↗ |
| K935049 | ELEGANCE NEONATAL TSH ELISA | Bioclone Australia Pty , Ltd. | 1994-10-03 | Traditional | PDF ↗ |
| K941146 | DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM | Dupont Medical Products | 1994-10-03 | Traditional | PDF ↗ |
| K942566 | IMX ULTRASENSISTIVE HTSH II | Abbott Laboratories | 1994-08-16 | Traditional | PDF ↗ |
| K934410 | AXSYM ULTRASENSITIVE HTSH | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K935119 | RADIAS 3RD GENERATION TSH IMMUNOASSAY | Bio-Rad | 1994-04-06 | Traditional | PDF ↗ |
| K930776 | COBAS CORE TSH EIA | Roche Diagnostic Systems, Inc. | 1993-12-03 | Traditional | PDF ↗ |
| K930006 | AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT | Bio-Chem Laboratory Systems, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K930050 | SIA THYROID STIMULATING HORMONE ELISA KIT | Sigma Chemical Co. | 1993-08-19 | Traditional | PDF ↗ |
| K931061 | RADIAS TSH ENZYME IMMUNOASSAY | Bio-Rad | 1993-06-16 | Traditional | PDF ↗ |
| K923532 | NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY | Solarcare Technologies Corp,Inc. | 1993-03-12 | Traditional | PDF ↗ |
| K925637 | ACCESS HTSH ASSAY | Bio-Rad Laboratories, Inc. | 1993-03-01 | Traditional | PDF ↗ |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Becton Dickinson Advanced Diagnostics | 1992-12-28 | Traditional | PDF ↗ |
| K923401 | DELFIA HTSH ULTRA KIT | Wallac OY | 1992-11-30 | Traditional | PDF ↗ |
| K922701 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K922138 | VISTA ULTRASENSITIVE HTSH ASSAY | Syva Co. | 1992-07-21 | Traditional | PDF ↗ |
| K922736 | KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA | Eastman Kodak Company | 1992-07-10 | Traditional | PDF ↗ |
| K921958 | ELISA TUBE TSH TEST | Bio Clinic Co. | 1992-07-02 | Traditional | PDF ↗ |
| K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 | Medix Biotech, Inc. | 1992-06-29 | Traditional | PDF ↗ |
| K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY | Biomerieux Vitek, Inc. | 1992-06-18 | Traditional | PDF ↗ |
| K920856 | VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS | Hycor Biomedical, Inc. | 1992-03-26 | Traditional | PDF ↗ |
| K920442 | IMMUCHEM TSH-MW ELISA | Icn Biomedicals, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K915195 | ENZYMUN-TEST TSH | Boehringer Mannheim Corp. | 1992-02-14 | Traditional | PDF ↗ |
| K914756 | ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT | Medix Biotech, Inc. | 1992-01-15 | Traditional | PDF ↗ |
| K913963 | IMMUCHEM NEONATAL TSH-MP ELISA | Icn Biomedicals, Inc. | 1991-12-13 | Traditional | PDF ↗ |
| K912852 | STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO | Baxter Healthcare Corp | 1991-09-27 | Traditional | PDF ↗ |
| K912583 | MAGIC LITE TSH (HS) IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-08-12 | Traditional | PDF ↗ |
| K912241 | STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1991-06-20 | Traditional | PDF ↗ |
| K912324 | NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-06-20 | Traditional | PDF ↗ |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-24 | Traditional | PDF ↗ |
Product code JLW · Class II · Clinical Chemistry. Data: openFDA.