Chdiagnostics, LLC
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Chdiagnostics, LLC makes
Chdiagnostics, LLC manufactures the Senova Blood Glucose Monitor, a device designed for measuring blood glucose levels in patients. It is intended for use in diabetes management to provide real-time glucose readings for monitoring and treatment decisions.
The Senova Blood Glucose Monitor is classified as a Class II device under FDA regulations and is supported by a 510(k) clearance. The company is based in the United States.
Catalogue
Senova(R) Blood Glucose Monitor Ref K032076
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Chdiagnostics, LLC, initiated on 2005-03-14. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 14 Mar 2005 Z-1546-05 Unclassified (pre-2012) Terminated A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
Full distribution text
- 14 Mar 2005 Z-1546-05 Unclassified (pre-2012) Terminated A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
Frequently asked questions
How many devices does Chdiagnostics, LLC have in the registry?
The registry currently lists 1 device for Chdiagnostics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Chdiagnostics, LLC's devices?
Among its 1 most recently registered device, Chdiagnostics, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Chdiagnostics, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Chdiagnostics, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Chdiagnostics, LLC?
FDA recall records list 1 recall initiated by Chdiagnostics, LLC, the most recent initiated on 14 Mar 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Chdiagnostics, LLC in the registry?
The most recently registered devices listed for Chdiagnostics, LLC include SENOVA(R) BLOOD GLUCOSE MONITOR.