Data / Medical devices / Radioimmunoassay, Thyroid-Stimulating Hormone / Japan
FDA-registered makers of Radioimmunoassay, Thyroid-Stimulating Hormone in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Radioimmunoassay, Thyroid-Stimulating Hormone (product code JLW). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Product code
- JLW
- Country
- Japan
Makers of Radioimmunoassay, Thyroid-Stimulating Hormone in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Sysmex Corporation | KOBE Hyogo, Japan | Manufacturer | 1 | October 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 1 | October 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 1 | August 29, 1997 | 0 | 0 | 0 | api.fda.gov |
| Hitachi High-Tech Corp., Naka Division | Hitachinaka-shi Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ids Co, Ltd | Kumamoto-Shi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kikuyo Factory | Kumamoto, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.