JLW
- Product code
- JLW
- Device name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1690
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 242 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251543 | 2026-02-06 | Siemens Healthcare Diagnostics, Inc. | Atellica® IM TSH3-Ultra II (TSH3ULII) | |
| K243570 | 2025-04-25 | Siemens Healthcare Diagnostics | Dimension LOCI Thyroid Stimulating Hormone Flex reag… | |
| K234091 | 2024-07-22 | Genalyte, Inc. | Maverick Diagnostic System TC1000; Maverick Test Pan… | — |
| K233050 | 2024-04-04 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | FDA |
Official FDA classification page: JLW
Classification and pathway per current FDA publications. Data from openFDA (CC0).