510(k) Report

Devices descending from K981100

3 later devices reach Stratus CS Trop Calpak 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
+1K983722Stratus CS Troponin I CalibratorDade Behring, Inc.19982—
+2K012233Stratus CS Troponin I CalibratorDade Behring, Inc.20011—