Data / Medical devices / Hemoglobin A1c Test System / Japan
FDA-registered makers of Hemoglobin A1c Test System in Japan: 6 establishments
6 establishments in Japan are registered with the FDA to make Hemoglobin A1c Test System (product code PDJ). 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
- Hemoglobin A1c Test System
- Product code
- PDJ
- Country
- Japan
Makers of Hemoglobin A1c Test System in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 1 | June 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 1 | June 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Hi-Tec, Inc. | Yamaguchi, Japan | Manufacturer | 1 | October 3, 2025 | 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 | |
| Oem Systems Co. Ltd. | UJI-SHI Kyoto, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEKISUI MEDICAL CO., LTD. Tsukuba Plant | Ryugasaki-shi Ibaraki, Japan | Contract 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.