Data / Medical devices / Calibrator, Secondary / Japan

FDA-registered makers of Calibrator, Secondary in Japan: 20 establishments

Name: FDA-registered makers of Calibrator, Secondary in Japan
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

20 establishments in Japan are registered with the FDA to make Calibrator, Secondary (product code JIT). 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: Calibrator, Secondary
Product code: JIT
Country: Japan

Makers of Calibrator, Secondary in Japan

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Tosoh Aia, Inc.	Toyama, Japan	Manufacturer	5	February 17, 2016	api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation MIE Office	Komono-cho, Mie-gun, Japan	Manufacturer	1	May 26, 1987	api.fda.gov
FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)	Amagasaki-shi Hyogo, Japan	Specification developer	1	May 26, 1987	api.fda.gov
ARKRAY Factory, Inc.	Koka-shi Shiga, Japan	Manufacturer	0		api.fda.gov
Arkray, Inc.	Kamigyo-ku Kyoto, Japan	Specification developer	0		api.fda.gov
Canon Medical Diagnostics Corporation Fuji Plant.	SUNTO-GUN Shizuoka, Japan	Contract manufacturer	0		api.fda.gov
Denka Co., Ltd.	GOSEN-SHI Niigata, Japan	Contract manufacturer, Manufacturer	0		api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, Japan	Contract manufacturer	0		api.fda.gov
Fujirebio Inc.	Sagamihara-shi Kanagawa, Japan	Manufacturer	0		api.fda.gov
Fujirebio Inc. Ube Facility	Yamaguchi, Japan	Manufacturer	0		api.fda.gov
Nipro Corporation Odate Factory	ODATE-SHI Akita, Japan	Contract manufacturer	0		api.fda.gov
Nittobo Medical Co., Ltd. Medical Development Center	Koriyama Fukushima, Japan	Contract manufacturer	0		api.fda.gov
Nagase Diagnostics Co., Ltd, Ohito Diagnostics Plant	Izunokuni-shi Shizuoka, Japan	Manufacturer	0		api.fda.gov
Otsuka Electronics Co., Ltd.	Koka-city Shiga, Japan	Contract manufacturer	0		api.fda.gov
PHC Corporation	Tako-machi Katori-gun Chiba, Japan	Complaint file establishment, Specification developer	0		api.fda.gov
SEKISUI MEDICAL CO., LTD. Tsukuba Plant	Ryugasaki-shi Ibaraki, Japan	Contract manufacturer	0		api.fda.gov
Shima Laboratories Co., Ltd.	ITABASHI-KU Tokyo, Japan	Contract manufacturer, Manufacturer	0		api.fda.gov
Shino-Test Corporation	Sagamihara Kanagawa, Japan	Manufacturer	0		api.fda.gov
Sysmex Corporation	KOBE Hyogo, Japan	Manufacturer	0		api.fda.gov
Sysmex Corporation Techno Park	KOBE Hyogo, Japan	Specification developer	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.