510(k) Report

Devices descending from K991795

1 later device reach Immulite Turbo Troponin I, Models LSKTI1, LSKTI5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp.200401