Data / Medical devices / Multi-Analyte Controls, All Kinds (Assayed) / Japan
FDA-registered makers of Multi-Analyte Controls, All Kinds (Assayed) in Japan: 5 establishments
5 establishments in Japan are registered with the FDA to make Multi-Analyte Controls, All Kinds (Assayed) (product code JJY). 0 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
- Multi-Analyte Controls, All Kinds (Assayed)
- Product code
- JJY
- Country
- Japan
Makers of Multi-Analyte Controls, All Kinds (Assayed) in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Denka Co., Ltd. | GOSEN-SHI Niigata, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Ltd. | Kyoto, Japan | Contract 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 | |
| Sysmex Corporation | KOBE Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 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.