510(k) Report

Devices descending from K974421

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022654Modification to Elecsys CK-MB Stat, Elecsys CK-MBRoche Diagnostics Corp.20022—
+2K132571Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics20131—
+3K140404Elecsys CK-MB Stat ImmunoassayRoche Diagnostics20140—