Accutech, LLC
Country not established
- Devices
- 1
What Accutech, LLC makes
Accutech, LLC produces the Cholestrak HDL cholesterol home test, a point-of-care device designed for self-monitoring of high-density lipoprotein (HDL) cholesterol levels in a home or clinical setting. This test provides rapid, qualitative results to help users assess their cardiovascular risk factors without requiring laboratory processing.
The Cholestrak HDL cholesterol home test is classified as a Class I medical device under FDA regulations and is authorised through the 510(k) clearance process. The company is based in the United States, where its products are listed for commercial distribution and use.
Catalogue
Cholestrak Hdl Cholesterol Home Test Ref K072836
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Accutech, LLC have in the registry?
The registry currently lists 1 device for Accutech, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accutech, LLC's devices?
Among its 1 most recently registered device, Accutech, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Accutech, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Accutech, LLC's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Accutech, LLC in the registry?
The most recently registered devices listed for Accutech, LLC include CHOLESTRAK HDL CHOLESTEROL HOME TEST.