SANDARE HEMOGLOBIN CONTROLS

SANDARE HEMOGLOBIN CONTROLS is an FDA 510(k)-cleared medical device (K792209) manufactured by Sandare Chemical Co., 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 December 3, 1979. Regulation: 8.