Axiom, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 4
What Axiom, Inc. makes
Axiom, Inc. manufactures point-of-care diagnostic tests for blood chemistry analysis, including cholesterol, uric acid, and triglycerides, as well as wound drainage devices designed for surgical and post-operative use.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the U.S. under FDA oversight.
Catalogue
Axiom Stable Ii Cholesterol Test Ref K842441
510(k) 510(k)Axiom Stable Ii Uric Acid Test Ref K842442
510(k) 510(k)Axiom Atraum Wound Drains Ref K883887
510(k) 510(k)Axiom Stable Ii Triglycerides Test Ref K842443
510(k) 510(k)
Frequently asked questions
How many devices does Axiom, Inc. have in the registry?
The registry currently lists 4 devices for Axiom, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Axiom, Inc.'s devices?
Among its 4 most recently registered devices, Axiom, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Axiom, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Axiom, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Axiom, Inc. in the registry?
The most recently registered devices listed for Axiom, Inc. include AXIOM STABLE II CHOLESTEROL TEST, AXIOM STABLE II URIC ACID TEST, AXIOM ATRAUM WOUND DRAINS and AXIOM STABLE II TRIGLYCERIDES TEST.