Roche’s Hematology Testing Solution Gains 510(k) Clearance

March 13, 2018

Roche announced that its cobas m 511 integrated hematology analyzer, a new hematology testing solution, received 510(k) clearance from the FDA.

The device identifies, counts and categorizes white and red blood cells and platelets, and presents digital images of the cell types.

The analyzer is designed to address difficulties in hematology testing by combining a cell counter, stainer, slidemaker and digital morphology analyzer.

View today's stories