
Hemocue, Inc.
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HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM is an FDA 510(k)-cleared medical device (K041234) manufactured by Hemocue, 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 June 9, 2004. Regulation: 8.