510(k) K133803

DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT by Diazyme Laboratories — Product Code LCP

K133803 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT". The FDA issued a decision of Substantially Equivalent on August 6, 2014. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Diazyme Laboratories has at least 10 other 510(k) clearances on record.