
Hemocue AB
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HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 is an FDA 510(k)-cleared medical device (K061047) manufactured by Hemocue AB. 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 7, 2006. Regulation: 8.