510(k) K003615

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS by Environmental Test Systems, Inc. — Product Code FKP

K003615 is an FDA 510(k) premarket notification submitted by Environmental Test Systems, Inc. for the device "STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Environmental Test Systems, Inc. has at least 7 other 510(k) clearances on record.