Data / Medical devices / Assay, Glycosylated Hemoglobin / Japan
FDA-registered makers of Assay, Glycosylated Hemoglobin in Japan: 7 establishments
7 establishments in Japan are registered with the FDA to make Assay, Glycosylated Hemoglobin (product code LCP). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Assay, Glycosylated Hemoglobin
- Product code
- LCP
- Country
- Japan
Makers of Assay, Glycosylated Hemoglobin in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant | Izunokuni-shi Shizuoka, Japan | Manufacturer | 1 | October 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tosoh Hi-Tec, Inc. | Yamaguchi, Japan | Manufacturer | 1 | September 16, 2008 | 0 | 0 | 0 | api.fda.gov |
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kainos Laboratories, Inc., Kasama Factory | Kasama 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.