About This 510(k) Submission
K003615 is an FDA 510(k) clearance for the STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS, a System, Dialysate Delivery, Single Patient (Class II — Special Controls, product code FKP), submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on February 1, 2001, 71 days after receiving the submission on November 22, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.