CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS is an FDA 510(k)-cleared medical device (K052525) manufactured by DFI Co., Ltd.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2006. Regulation: 8.