510(k) K170147

Lucica Glycated Albumin-L by Asahi Kasei Pharma Corporation — Product Code LCP

K170147 is an FDA 510(k) premarket notification submitted by Asahi Kasei Pharma Corporation for the device "Lucica Glycated Albumin-L". The FDA issued a decision of Substantially Equivalent on October 12, 2017. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.