510(k) K022654

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB by Roche Diagnostics Corp. — Product Code JHY

K022654 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.