Automated differential cell counters
This article was originally published in The Gray Sheet
Executive Summary
Downclassification of the devices used with immature or abnormal blood cells from Class III to Class II with special controls based on information submitted in a reclassification petition by the International Society for Laboratory Hematology is effective Feb. 13, FDA announces in the Jan. 14 Federal Register. FDA's Dec. 4, 2001 1automated differential cell counter final guidance will serve as a special control...