510(k) K801300

DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) by E.I. Dupont DE Nemours & Co., Inc. — Product Code JIW

K801300 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)". The FDA issued a decision of Substantially Equivalent on July 8, 1980. The device falls under product code JIW (Calibrator, Surrogate), 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.