IQ 200 URINE ANALYZER BODY FLUIDS MODULE

IQ 200 URINE ANALYZER BODY FLUIDS MODULE is an FDA 510(k)-cleared medical device (K050235) manufactured by Iris International, 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 March 22, 2005. Regulation: 8.