HMP CONTROLS (TAS) RAPIDPOINT

HMP CONTROLS (TAS) RAPIDPOINT is an FDA 510(k)-cleared medical device (K994159) manufactured by Cardiovascular Diagnostics, 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 February 14, 2000. Regulation: 8.