510(k) K984288

VITROS CHEMISTRY PRODUCTS PHBR SLIDES by Ortho-Clinical Diagnostics, Inc. — Product Code DLZ

K984288 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 January 26, 1999. 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.