Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / Japan
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Japan: 17 establishments
17 establishments in Japan are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 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
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- Japan
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 7 | December 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 2 | February 11, 2003 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 2 | February 11, 2003 | 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 | |
| Canon Medical Diagnostics Corporation Fuji Plant. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office | MINAMIASHIGARA-SHI Kanagawa, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Inc. | Sagamihara-shi Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant | Izunokuni-shi Shizuoka, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PHC Corporation | TOON Ehime, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PHC Corporation | MIMA Tokushima, 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 | |
| Shima Laboratories Co., Ltd. | ITABASHI-KU Tokyo, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takasaki Plant, Nippon Kayaku Co., Ltd. | TAKASAKI-SHI Gunma, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Hi-Tec, Inc. | Yamaguchi, 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.