510(k) K943027

CHOLESTEROL QVET by Prisma Systems — Product Code CHH

K943027 is an FDA 510(k) premarket notification submitted by Prisma Systems for the device "CHOLESTEROL QVET". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Prisma Systems has at least 10 other 510(k) clearances on record.