510(k) K163078

DC-UIBC-CAL by Sekisui Diagnostics P.E.I., Inc. — Product Code JIT

K163078 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "DC-UIBC-CAL". The FDA issued a decision of Substantially Equivalent on December 8, 2016. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Sekisui Diagnostics P.E.I., Inc. has at least 5 other 510(k) clearances on record.