Akers Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Akers Laboratories, Inc. makes
Akers Laboratories, Inc. manufactures blood cell separation devices, rapid lithium testing systems, and in vitro diagnostic assays for detecting heparin-induced thrombocytopenia, including platelet factor 4 antibody tests.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) premarket notification process. The company operates from the United States.
Catalogue
Akers Laboratories Inc. Blood Cell Separator Ref K030815
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Instaread Lithium System Ref K031579
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Akers Laboratories, Inc. have in the registry?
The registry currently lists 3 devices for Akers Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Akers Laboratories, Inc.'s devices?
Among its 3 most recently registered devices, Akers Laboratories, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Akers Laboratories, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Akers Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Akers Laboratories, Inc. in the registry?
The most recently registered devices listed for Akers Laboratories, Inc. include AKERS LABORATORIES INC. BLOOD CELL SEPARATOR, HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY and INSTAREAD LITHIUM SYSTEM.