510(k) K953854

WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE by Integrated Biomedical Technology, Inc. — Product Code FKP

K953854 is an FDA 510(k) premarket notification submitted by Integrated Biomedical Technology, Inc. for the device "WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE". The FDA issued a decision of Substantially Equivalent on Mar 11, 1996. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Integrated Biomedical Technology, Inc. has 2 other 510(k) clearances on record.