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Sysmex’s Automated Blood Coagulation Analyzer CN™-6000 Receives U.S. FDA 510(k) Clearance
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its "Automated Blood Coagulation Analyzer CN-6000."
This clearance covers not only the analyzer itself but also five reagent products* used in commonly performed blood coagulation tests.
Sysmex will continue preparations for the early market launch of this product in the United States. Furthermore, to expand our business in the U.S. hemostasis testing market, we will continue efforts to obtain clearance for the Automated Blood Coagulation Analyzer CN-3000 and additional reagent applications.
*Reagent products included in this 510(k) submission:
- Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
- Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
- Fibrinogen (Fbg) with Dade® Thrombin Reagent
- Antithrombin (AT) with INNOVANCE® Antithrombin
- D-dimer with INNOVANCE® D-Dimer
- The purpose of this news is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising, or medical advice. The information contained in this press release is current as of the date of the announcement but may be subject to change without prior notice.