Array Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Array Medical, Inc. makes
Array Medical, Inc. manufactures coagulation testing devices, including the PlateletWorks system for platelet function analysis and the MAX-ACT for activated clotting time (ACT) monitoring. Their portfolio also includes the Actalyke ACTivated Clotting Time Test System, which comprises electronic clotting tubes, whole blood quality control kits, and disposable clotting tubes for point-of-care blood coagulation assessments.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company operates within the United States, adhering to applicable medical device compliance standards.
Catalogue
Plateletworks Ref K990398
Regimes: 510(k) Registry: 510(k)Max-Act Ref K983649
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Array Medical, Inc. have in the registry?
The registry currently lists 3 devices for Array Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Array Medical, Inc.'s devices?
Among its 3 most recently registered devices, Array Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Array Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Array Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Array Medical, Inc. in the registry?
The most recently registered devices listed for Array Medical, Inc. include PLATELETWORKS, MAX-ACT and ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE.