
Dade Behring, Inc.
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SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 is an FDA 510(k)-cleared medical device (K031377) manufactured by Dade Behring, 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 September 7, 2003. Regulation: 8.