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Stanbio Laboratory
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STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM is an FDA 510(k)-cleared medical device (K090093) manufactured by Stanbio Laboratory. 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, 2009. Regulation: 8.