Actimed Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Actimed Laboratories, Inc. makes
Actimed Laboratories, Inc. manufactures in-vitro diagnostic reagents, including the ENA-C-T Total Cholesterol Test and its Model F 20000 variant for physician-directed use, as well as assayed Total Cholesterol Controls for laboratory quality assurance.
These products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records in the U.S. The company is based in the United States.
Catalogue
Ena-C-T Total Cholesterol Test Ref K960377
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ena-C-T Assayed Total Cholesterol Controls Ref K960378
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Actimed Laboratories, Inc. have in the registry?
The registry currently lists 3 devices for Actimed Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Actimed Laboratories, Inc.'s devices?
Among its 3 most recently registered devices, Actimed Laboratories, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Actimed Laboratories, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Actimed Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Actimed Laboratories, Inc. in the registry?
The most recently registered devices listed for Actimed Laboratories, Inc. include ENA-C-T TOTAL CHOLESTEROL TEST, ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE) and ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS.