510(k) K821399

MACRO-VUE CARD TEST, NETILMICIN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LCE

K821399 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MACRO-VUE CARD TEST, NETILMICIN". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), a Class II device regulated under 21 CFR 862.3450. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.