510(k) K810597

MACRO-VUE CARD TEST by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KLB

K810597 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MACRO-VUE CARD TEST". The FDA issued a decision of Substantially Equivalent on March 17, 1981. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.