510(k) K121558

DIAZYME HSCRP POC TEST KIT by Diazyme Laboratories — Product Code DCK

K121558 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HSCRP POC TEST KIT". The FDA issued a decision of Substantially Equivalent on September 21, 2012. The device falls under product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Diazyme Laboratories has at least 10 other 510(k) clearances on record.