510(k) Report

Devices descending from K981098

8 later devices reach Stratus CS Cardiac Troponin I Testpak through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…Dade Behring, Inc.2005011
+1K033487Stratus CS Acute Care Troponin I Testpak, Model CctniDade Behring, Inc.200361
+1K984093Stratus (R) CS Cardiac Troponin I (Trop) TestpakDade Behring, Inc.19987—
+2K100130Pathfast Ctni-II Test, Pathfast Ctni Calibrators, Pathfast Sample Diluent 2Mitsubishi Chemical Medience CO20114—
+3K231974PATHFAST®hs-cTnI-IIPhc Corporation20242—
+3K130603Pathfast CTNL CalibratorsMitsubishi Chemical Medience Corporation20140—
+4K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20251—
+5K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.20260—