JLW — Radioimmunoassay, Thyroid-Stimulating Hormone Class II
FDA product code JLW covers "Radioimmunoassay, Thyroid-Stimulating Hormone", a Class II medical device regulated under 21 CFR 862.1690. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JLW
- Device Class
- Class II
- Regulation Number
- 862.1690
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251543 | Siemens Healthcare Diagnostics | Atellica® IM TSH3-Ultra II (TSH3ULII) | Feb 6, 2026 |
| K243570 | Siemens Healthcare Diagnostics | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens | Apr 25, 2025 |
| K234091 | Genalyte | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Jul 22, 2024 |
| K233050 | Siemens Healthcare Diagnostics | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Apr 4, 2024 |
| K222116 | Siemens Healthcare Diagnostics | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL | Jul 13, 2023 |
| K221225 | Beckman Coulter | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Nov 10, 2022 |
| K190773 | Roche Diagnostics | Elecsys TSH | Apr 16, 2019 |
| K170232 | Boditech Med | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Oct 13, 2017 |
| K171103 | Fujirebio Diagnostics | Lumipulse G TSH-III Immunoreaction Cartridges | Jul 28, 2017 |
| K162698 | Shenzhen New Industries Biomedical Engineering Co | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Jul 14, 2017 |
| K162606 | Roche Diagnostics | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Jan 23, 2017 |
| K160541 | Sysmex America | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrat | Oct 21, 2016 |
| K153651 | Beckman Coulter | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immu | Aug 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 | Nov 20, 2015 |
| K150403 | Siemens Healthcare Diagnostics | ADVIA Centaur TSH3-Ultra | May 1, 2015 |
| K141999 | Siemens Healthcare Diagnostics | ADVIA CENTAUR TSH | Apr 22, 2015 |
| K131928 | Nanoentek Usa | FREND TSH (REAGENT CARTRIDGE) | Mar 14, 2014 |
| K130469 | Diasorin | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTR | Apr 5, 2013 |
| K110761 | Magnabiosciences | MICT TSH | Mar 9, 2012 |