Data / Medical devices / Calibrator, Multi-Analyte Mixture / Japan
FDA-registered makers of Calibrator, Multi-Analyte Mixture in Japan: 9 establishments
9 establishments in Japan are registered with the FDA to make Calibrator, Multi-Analyte Mixture (product code JIX). 2 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
- Calibrator, Multi-Analyte Mixture
- Product code
- JIX
- Country
- Japan
Makers of Calibrator, Multi-Analyte Mixture in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| FUJIFILM Healthcare Manufacturing Corporation MIE Office | Komono-cho, Mie-gun, Japan | Manufacturer | 1 | November 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) | Amagasaki-shi Hyogo, Japan | Specification developer | 1 | November 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Biolis Medical Corp. | Hino Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Furuno Electric Co., Ltd. | NISHINOMIYA-CITY Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Ltd. | Kyoto, Japan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeol Ltd. | Musashimurayama Tokyo, 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 | |
| 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.