Bicarbolyte Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Bicarbolyte Corp. makes
Bicarbolyte Corp. manufactures hemodialysate solutions and powdered bicarbonate concentrate, which are used in renal dialysis treatments to regulate electrolyte balance and acid-base levels in patients.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hemodialysate Solutions Ref K843866
Regimes: 510(k) Registry: 510(k)Powdered Bicarbonate Concentrate Ref K865078
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bicarbolyte Corp. have in the registry?
The registry currently lists 2 devices for Bicarbolyte Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bicarbolyte Corp.'s devices?
Among its 2 most recently registered devices, Bicarbolyte Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bicarbolyte Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bicarbolyte Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bicarbolyte Corp. in the registry?
The most recently registered devices listed for Bicarbolyte Corp. include HEMODIALYSATE SOLUTIONS and POWDERED BICARBONATE CONCENTRATE.