510(k) Report

Devices descending from K004002

2 later devices reach Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022118Immulite Turbo CK-MB, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)Diagnostic Products Corp.200211
+2K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp.200401