![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 » FDA Clears Complete Blood Cell Count Analyzer
FDA Clears Complete Blood Cell Count Analyzer
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
The FDA has granted premarket clearance and a waiver under the Clinical Laboratory Improvement Amendments of 1988 to Sysmex America for its complete blood cell count test.
Broadened access to the XW-100 automated hematology analyzer for patients at least 2-years-old in additional healthcare settings such as non-traditional laboratories, will allow for faster availability of results, the agency said.
The analyzer provides results from a complete blood count test more quickly than the standard 24-hour delivery.
Upcoming Events
-
21Oct