Tomen America, Inc.
Country not established
- Devices
- 1
What Tomen America, Inc. makes
Tomen America, Inc. manufactures the GLYCOMARK, a diagnostic device used for assessing glycemic control in patients with diabetes by measuring glycated hemoglobin levels in whole blood samples.
The GLYCOMARK is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) clearance pathway. The company is based in the United States.
Catalogue
Glycomark Ref K031604
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tomen America, Inc. have in the registry?
The registry currently lists 1 device for Tomen America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tomen America, Inc.'s devices?
Among its 1 most recently registered device, Tomen America, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Tomen America, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tomen America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tomen America, Inc. in the registry?
The most recently registered devices listed for Tomen America, Inc. include GLYCOMARK.