Actio, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Actio, Inc. makes
Actio, Inc. manufactures urinalysis controls, including assayed and unassayed variants, as well as metal toxicology controls and cholineesterase assay controls. These products are designed for laboratory quality assurance in urine testing and toxicology assessments.
The company’s portfolio consists of Class I medical devices, regulated under the FDA’s 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Shape-Actio Metal Toxicology Control Ref K890721
Regimes: 510(k) Registry: 510(k)Shape-Actio Urinalysis Controls Ref K890442
Regimes: 510(k) Registry: 510(k)Assayed Cholinesterase Control Ref K885282
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Actio, Inc. have in the registry?
The registry currently lists 4 devices for Actio, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Actio, Inc.'s devices?
Among its 4 most recently registered devices, Actio, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Actio, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Actio, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Actio, Inc. in the registry?
The most recently registered devices listed for Actio, Inc. include SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY), SHAPE-ACTIO METAL TOXICOLOGY CONTROL, SHAPE-ACTIO URINALYSIS CONTROLS and ASSAYED CHOLINESTERASE CONTROL.