510(k) Report

Devices descending from K022654

2 later devices reach Modification to Elecsys CK-MB Stat, Elecsys CK-MB through their predicates, nearest generation first.

Generation	Number	Device	Applicant	Decided	Own descendants	Recalls
+1	K132571	Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay	Roche Diagnostics	2013	1	—
+2	K140404	Elecsys CK-MB Stat Immunoassay	Roche Diagnostics	2014	0	—