Skyla Corporation H.S.P.B
TaiwanFDA applicant, unverified
- Devices
- 1
What Skyla Corporation H.S.P.B makes
Skyla Corporation manufactures the skyla Hi Hemoglobin A1c System, which includes a dedicated analyzer and a reagent kit designed for measuring hemoglobin A1c levels in blood samples. This system is intended for use in clinical settings to monitor long-term blood glucose control in patients with diabetes.
The skyla Hi Hemoglobin A1c System is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) Ref K173127
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Skyla Corporation H.S.P.B have in the registry?
The registry currently lists 1 device for Skyla Corporation H.S.P.B. Devices recorded under merged duplicate company entries are counted once.
Which registries list Skyla Corporation H.S.P.B's devices?
Among its 1 most recently registered device, Skyla Corporation H.S.P.B has devices listed in FDA 510(k) (1 device).
What risk classes do Skyla Corporation H.S.P.B's devices fall under?
Among its 1 most recently registered device, the classes recorded for Skyla Corporation H.S.P.B's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Skyla Corporation H.S.P.B in the registry?
The most recently registered devices listed for Skyla Corporation H.S.P.B include skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit).