
Diagnostica Stago, Inc.
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STA- COAG CONTROL (N+ABN) PLUS is an FDA 510(k)-cleared medical device (K120014) manufactured by Diagnostica Stago, 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 13, 2013. Regulation: 8.