Cone Bioproducts
Country not established
- Devices
- 3
What Cone Bioproducts makes
Cone Bioproducts manufactures linearity sets and liquid chemistry controls for hemoglobin A1C testing, including dedicated A1C linearity standards and hemoglobin control sets for laboratory use.
These products are classified as Class I medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
HBA1C Linearity Set Ref K052010
510(k) 510(k)Cone-Trol Hemoglobin A1C Control Set Ref K121534
510(k) 510(k)Cone-Trol Liquid Chemistry Controls Ref K121759
510(k) 510(k)
Frequently asked questions
How many devices does Cone Bioproducts have in the registry?
The registry currently lists 3 devices for Cone Bioproducts. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cone Bioproducts's devices?
Among its 3 most recently registered devices, Cone Bioproducts has devices listed in FDA 510(k) (3 devices).
What risk classes do Cone Bioproducts's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cone Bioproducts's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cone Bioproducts in the registry?
The most recently registered devices listed for Cone Bioproducts include HBA1C LINEARITY SET, CONE-TROL HEMOGLOBIN A1C CONTROL SET and CONE-TROL LIQUID CHEMISTRY CONTROLS.