510(k) K992132

CHOLESITE TEST SYSTEM by Gds Technology, LLC — Product Code CHH

K992132 is an FDA 510(k) premarket notification submitted by Gds Technology, LLC for the device "CHOLESITE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 1999. The device falls under product code CHH (Enzymatic Esterase--Oxidase, Cholesterol), a Class I device regulated under 21 CFR 862.1175. Gds Technology, LLC has at least 7 other 510(k) clearances on record.