| K251543 | siemens healthcare diagnostics | Atellica® IM TSH3-Ultra II (TSH3ULII) | February 6, 2026 |
| K243570 | siemens healthcare diagnostics | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens | April 25, 2025 |
| K234091 | genalyte | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | July 22, 2024 |
| K233050 | siemens healthcare diagnostics | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | April 4, 2024 |
| K222116 | siemens healthcare diagnostics | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL | July 13, 2023 |
| K221225 | beckman coulter | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | November 10, 2022 |
| K190773 | roche diagnostics | Elecsys TSH | April 16, 2019 |
| K170232 | boditech med | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | October 13, 2017 |
| K171103 | fujirebio diagnostics | Lumipulse G TSH-III Immunoreaction Cartridges | July 28, 2017 |
| K162698 | shenzhen new industries biomedical engineering co | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | July 14, 2017 |
| K162606 | roche diagnostics | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | January 23, 2017 |
| K160541 | sysmex america | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrat | October 21, 2016 |
| K153651 | beckman coulter | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immu | August 18, 2016 |
| K160647 | siemens healthcare diagnostics | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | May 31, 2016 |
| K151792 | siemens healthcare diagnostics | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators | November 20, 2015 |
| K150403 | siemens healthcare diagnostics | ADVIA Centaur TSH3-Ultra | May 1, 2015 |
| K141999 | siemens healthcare diagnostics | ADVIA CENTAUR TSH | April 22, 2015 |
| K131928 | nanoentek usa | FREND TSH (REAGENT CARTRIDGE) | March 14, 2014 |
| K130469 | diasorin | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTR | April 5, 2013 |
| K110761 | magnabiosciences | MICT TSH | March 9, 2012 |