510(k) K103557

DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET by Diazyme Laboratories — Product Code DCK

K103557 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET". The FDA issued a decision of Substantially Equivalent on April 27, 2011. 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.