510(k) K073488

DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX by Diazyme Laboratories — Product Code MSJ

K073488 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX". The FDA issued a decision of Substantially Equivalent on March 7, 2008. The device falls under product code MSJ (Apolipoproteins), a Class I device regulated under 21 CFR 862.1475. Diazyme Laboratories has at least 10 other 510(k) clearances on record.