510(k) K843007

CARDI-CK EIA TEST KIT CK-MB ISOENZYME by Intl. Immunoassay Laboratories, Inc. — Product Code JHS

K843007 is an FDA 510(k) premarket notification submitted by Intl. Immunoassay Laboratories, Inc. for the device "CARDI-CK EIA TEST KIT CK-MB ISOENZYME". The FDA issued a decision of Substantially Equivalent on September 7, 1984. The device falls under product code JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Intl. Immunoassay Laboratories, Inc. has at least 10 other 510(k) clearances on record.