510(k) K901858

MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST by E.I. Dupont DE Nemours & Co., Inc. — Product Code CET

K901858 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST". The FDA issued a decision of Substantially Equivalent on June 12, 1990. The device falls under product code CET (Olive Oil Emulsion (Turbidimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.