
Roche Diagnostics Hematology, Inc.
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cobas m 511 integrated hematology analyzer is an FDA 510(k)-cleared medical device (K171655) manufactured by Roche Diagnostics Hematology, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 2018. Regulation: 8.