510(k) K182063

VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System by Ortho-Clinical Diagnostics, Inc. — Product Code JFY

K182063 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System". The FDA issued a decision of Substantially Equivalent on October 30, 2018. The device falls under product code JFY (Enzymatic Method, Creatinine), a Class II device regulated under 21 CFR 862.1225. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.