Advanced Bio Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Advanced Bio Systems, Inc. makes
Advanced Bio Systems, Inc. manufactures insulin delivery devices, including the MINI-PUMP U-100, a portable insulin pump for subcutaneous administration of U-100 insulin. The company also produces components and systems for dental oral care, though specific device names are not provided.
The company’s insulin pumps fall under FDA Class II regulation and are listed via the 510(k) pathway. Dental oral care systems are similarly classified as Class II devices. The manufacturer is based in the United States.
Catalogue
Dental Oral Care Systems & Components Ref K844480
Regimes: 510(k) Registry: 510(k)Mini-Pump U-100 Ref K840616
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Bio Systems, Inc. have in the registry?
The registry currently lists 2 devices for Advanced Bio Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Bio Systems, Inc.'s devices?
Among its 2 most recently registered devices, Advanced Bio Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Advanced Bio Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Advanced Bio Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Bio Systems, Inc. in the registry?
The most recently registered devices listed for Advanced Bio Systems, Inc. include DENTAL ORAL CARE SYSTEMS & COMPONENTS and MINI-PUMP U-100.