SERIM DIALYSATE MONITOR TEST STRIP

SERIM DIALYSATE MONITOR TEST STRIP is an FDA 510(k)-cleared medical device (K043031) manufactured by Serim Research Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 12, 2005. Regulation: 8.