510(k) K821771

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

K821771 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MACRO-VUE CARD TEST, AMIKACIN". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.