510(k) K060619

DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A by Diazyme Laboratories — Product Code KHS

K060619 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A". The FDA issued a decision of Substantially Equivalent on July 21, 2006. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Diazyme Laboratories has at least 10 other 510(k) clearances on record.