510(k) K130332

VITROS CHEMISTRY PRODUCTS TRIG SLIDES by Ortho-Clinical Diagnostics, Inc. — Product Code CDT

K130332 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS TRIG SLIDES". The FDA issued a decision of Substantially Equivalent on May 31, 2013. The device falls under product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.