510(k) K171247

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test by Epocal, Inc. — Product Code CDS

K171247 is an FDA 510(k) premarket notification submitted by Epocal, Inc. for the device "epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test". The FDA issued a decision of Substantially Equivalent on January 17, 2018. The device falls under product code CDS (Electrode, Ion Specific, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Epocal, Inc. has at least 6 other 510(k) clearances on record.