510(k) K922700

DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. by E.I. Dupont DE Nemours & Co., Inc. — Product Code JHY

K922700 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.". The FDA issued a decision of Substantially Equivalent on August 20, 1992. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.