
Diagnostica-Stago
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ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN is an FDA 510(k)-cleared medical device (K010455) manufactured by Diagnostica-Stago. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 2001. Regulation: 8.