Amdev, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Amdev, Inc. makes
Amdev, Inc. manufactures point-of-care blood chemistry analyzers, including models for measuring glucose levels and electrolytes such as sodium, potassium, and ionized calcium. Their product line also includes devices for analyzing arterial blood gases and related parameters, designed for use in clinical and emergency settings.
The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. These products are intended for use in the United States, adhering to applicable medical device compliance standards.
Catalogue
Lytening 2 Ref K863521
Regimes: 510(k) Registry: 510(k)Lytening Tm 6/R Ref K904726
Regimes: 510(k) Registry: 510(k)Apec Glucose Analyzer Ref K890524
Regimes: 510(k) Registry: 510(k)Lytening 5 Ref K880917
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Lytening 1 Ref K853832
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amdev, Inc. have in the registry?
The registry currently lists 6 devices for Amdev, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amdev, Inc.'s devices?
Among its 6 most recently registered devices, Amdev, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Amdev, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Amdev, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amdev, Inc. in the registry?
The most recently registered devices listed for Amdev, Inc. include LYTENING 2, LYTENING TM 6/R, APEC GLUCOSE ANALYZER and LYTENING 5.