Berlex Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Berlex Laboratories, Inc. makes
Berlex Laboratories, Inc. manufactures solution transfer sets, which are sterile, single-use devices designed for transferring intravenous fluids or medications between containers without direct manual handling.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Solution Administration Set (W/O Needle) Ref K821995
Regimes: 510(k) Registry: 510(k)Solution Transfer Set Ref K834500
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Berlex Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Berlex Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Berlex Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Berlex Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Berlex Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Berlex Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Berlex Laboratories, Inc. in the registry?
The most recently registered devices listed for Berlex Laboratories, Inc. include SOLUTION ADMINISTRATION SET (W/O NEEDLE) and SOLUTION TRANSFER SET.