510(k) K160762

Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set by Diazyme Laboratories — Product Code LCP

K160762 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set". The FDA issued a decision of Substantially Equivalent on November 21, 2016. 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.