510(k) K161646

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set by Diazyme Laboratories — Product Code CGN

K161646 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set". The FDA issued a decision of Substantially Equivalent on November 4, 2016. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Diazyme Laboratories has at least 10 other 510(k) clearances on record.