![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Siemens Healthcare Wins Clearance for Sysmex CS-5100 System
Siemens Healthcare Wins Clearance for Sysmex CS-5100 System
![](https://www.fdanews.com/ext/resources/test/Device_Images3/siemens.jpg?t=1452813799&width=430)
Siemens Healthcare has scored FDA 510(k) clearance for its Sysmex CS-5100 system, a hemostasis system that enables automated, standardized sample management.
The system — which also allows for the automated detection of unsuitable samples — helps high-volume laboratories achieve high-level accuracy, according to the company.
Siemens adds that preanalytical errors and unsuitable samples account for up to 70 percent of mistakes in laboratory diagnostics. — Michael Cipriano
Upcoming Events
-
21Oct