Vivachek Laboratories, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Vivachek Laboratories, Inc. makes
Vivachek Laboratories, Inc. manufactures blood glucose monitoring systems, including strip-based and smart meter models with features such as wireless syncing, sound-based feedback, and simplified interfaces for diabetes management.
The company’s products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The devices are intended for use in the United States.
Catalogue
VivaChek Ino Blood Glucose Monitoring System Ref K160179
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Vivachek Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Vivachek Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vivachek Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Vivachek Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Vivachek Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Vivachek Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vivachek Laboratories, Inc. in the registry?
The most recently registered devices listed for Vivachek Laboratories, Inc. include VivaChek Ino Blood Glucose Monitoring System and VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System.