Applied Clinical Research Laboratories
Country not established
- Devices
- 2
What Applied Clinical Research Laboratories makes
Applied Clinical Research Laboratories produces laboratory controls and reagents for glucose monitoring, including reference standards for glycated hemoglobin (glyco.) testing and a spin-based sample preparation device (Glyco-Spin) designed for blood specimen processing.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates within the United States.
Catalogue
Normal And Elevated Control For Glyco. Ref K803186
Regimes: 510(k) Registry: 510(k)Glyco-Spin Ref K792086
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Applied Clinical Research Laboratories have in the registry?
The registry currently lists 2 devices for Applied Clinical Research Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Applied Clinical Research Laboratories's devices?
Among its 2 most recently registered devices, Applied Clinical Research Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Applied Clinical Research Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Applied Clinical Research Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Applied Clinical Research Laboratories in the registry?
The most recently registered devices listed for Applied Clinical Research Laboratories include NORMAL AND ELEVATED CONTROL FOR GLYCO. and GLYCO-SPIN.