510(k) K760045

KIT, RADIOASSAY, SERUM IRON by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JJA

K760045 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "KIT, RADIOASSAY, SERUM IRON". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code JJA (Radio-Labeled Iron Method, Iron (Non-Heme)), a Class I device regulated under 21 CFR 862.1410. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.