FDA gives 510(k) approval to cobas m 511 analyzer for hematology testing.- Roche.
Roche announced that its new hematology testing solution, the cobas m 511 integrated hematology analyzer, has received 510(k) clearance from the FDA. The cobas m 511 analyzer, featuring patented Bloodhound technology, is designed to address the challenges of hematology testing by combining a cell counter, slide maker and stainer and a digital morphology analyzer into one integrated solution. It allows labs to report the complete blood count (CBC), white blood cell differential and reticulocyte results, and prepare, stain and analyze blood smears for abnormal results through a single, integrated process.
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