Squibb-Novo, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Squibb-Novo, Inc. makes
Squibb-Novo, Inc. manufactures insulin delivery systems, including the NOVOLINPEN DIAL-A-DOSE, a pre-filled insulin pen for subcutaneous administration, and the NOVOPEN System, a disposable insulin syringe designed for single-use dosing.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States, adhering to domestic regulatory requirements for medical devices.
Catalogue
Novolinpen Dial-A-Dose Insulin Delivery System Ref K872805
Regimes: 510(k) Registry: 510(k)Novopen System (Insulin Syringe) Ref K861686
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Squibb-Novo, Inc. have in the registry?
The registry currently lists 2 devices for Squibb-Novo, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Squibb-Novo, Inc.'s devices?
Among its 2 most recently registered devices, Squibb-Novo, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Squibb-Novo, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Squibb-Novo, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Squibb-Novo, Inc. in the registry?
The most recently registered devices listed for Squibb-Novo, Inc. include NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM and NOVOPEN SYSTEM (INSULIN SYRINGE).