510(k) K935543

ACA PLUS FERRITIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code JIX

K935543 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA PLUS FERRITIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.