510(k) K161721

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set by Diazyme Laboratories — Product Code CDD

K161721 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set". The FDA issued a decision of Substantially Equivalent on September 20, 2016. The device falls under product code CDD (Radioassay, Vitamin B12), a Class II device regulated under 21 CFR 862.1810. Diazyme Laboratories has at least 10 other 510(k) clearances on record.