Differential cell counters
This article was originally published in The Gray Sheet
Executive Summary
Automated systems will be reclassified from Class III to Class II with special controls based on information submitted in a reclassification petition by the International Society for Laboratory Hematology, FDA proposes in a May 9 Federal Register notice. FDA had previously rejected a downclassification submission filed by Abbott (1"The Gray Sheet" Jan. 25, 1999, p. 8). The guidance "Automated Differential Cell Counters for Immature or Abnormal Blood Cells" will serve as a special control. Comments are due by Aug. 7