510(k) K132571

ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY by Roche Diagnostics — Product Code JHY

K132571 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 18, 2013. The device falls under product code JHY (Colorimetric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Roche Diagnostics has at least 10 other 510(k) clearances on record.