510(k) K210858

VITROS Chemistry Products PHBR Slides by Ortho-Clinical Diagnostics, Inc. — Product Code DLZ

K210858 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS Chemistry Products PHBR Slides". The FDA issued a decision of Substantially Equivalent on August 13, 2021. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.