Exocell, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Exocell, Inc. makes
Exocell, Inc. manufactures laboratory reagents and diagnostic devices for measuring albumin and glycated hemoglobin levels, including DIALBUMIN for albumin quantification, GLYCABEN and GLYCACOR for glycated hemoglobin analysis, and ALBUWELL for albumin correction. The company also produces ACC.U.DIAL, a device for precise albumin-adjusted hemoglobin measurement.
The portfolio includes Class I and Class II devices, all of which are subject to FDA 510(k) clearance. These products are listed under the FDA’s regulatory framework and are intended for use in clinical and laboratory settings. The company is headquartered in the United States.
Catalogue
Dialbumin Ref K891544
510(k) 510(k)Glycaben Ref K893453
510(k) 510(k)Glycacor Ref K980888
510(k) 510(k)Albuwell Ref K884146
510(k) 510(k)Acc.u.dial Ref K894423
510(k) 510(k)
Frequently asked questions
How many devices does Exocell, Inc. have in the registry?
The registry currently lists 5 devices for Exocell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exocell, Inc.'s devices?
Among its 5 most recently registered devices, Exocell, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Exocell, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Exocell, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Exocell, Inc. in the registry?
The most recently registered devices listed for Exocell, Inc. include DIALBUMIN, GLYCABEN, GLYCACOR and ALBUWELL.