510(k) K864893

ANTI-CYTOKERATIN MONOCLONAL ANTIBODY by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LYE

K864893 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "ANTI-CYTOKERATIN MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on July 7, 1988. The device falls under product code LYE (Cytokeratins), a Class II device regulated under 21 CFR 866.5550. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.