510(k) K143470

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set by Diazyme Laboratories — Product Code GIS

K143470 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set". The FDA issued a decision of Substantially Equivalent on January 31, 2016. The device falls under product code GIS (Test, Fibrinogen), a Class II device regulated under 21 CFR 864.7340. Diazyme Laboratories has at least 10 other 510(k) clearances on record.