510(k) K061296

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR by Diazyme Laboratories — Product Code LPS

K061296 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR". The FDA issued a decision of Substantially Equivalent on June 13, 2006. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Diazyme Laboratories has at least 10 other 510(k) clearances on record.