RED BLOOD CELL COUNT & HEMATOCRIT CNTL

RED BLOOD CELL COUNT & HEMATOCRIT CNTL is an FDA 510(k)-cleared medical device (K801267) manufactured by Bioscientific. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 1980. Regulation: 8.