510(k) Report

Devices descending from K030057

1 later device reach Spectral Cardiac Status CK-MB/Myoglobin/Troponin I 3-in-1 Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050975Nano-Check Ami 3 in 1 Cardiac Disease Test for Cardiac Troponin I, Creatine Kinase MB…Nano-Ditech Co.20060—