510(k) K171655

cobas m 511 integrated hematology analyzer by Roche Diagnostics Hematology, Inc. — Product Code GKZ

K171655 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Hematology, Inc. for the device "cobas m 511 integrated hematology analyzer". The FDA issued a decision of Substantially Equivalent on March 2, 2018. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220.