510(k) Report

Devices descending from K003696

2 later devices reach Stratus CS Stat Fluorometric Analyzer BHCG Testpak,Test System, Model Cbhcg… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060548Stratus CS Acute Care Betahcg and NT-Probnp Testpak and Testpak Assay, Calpak and DilpakDade Behring, Inc.200612
+2K071834Stratus CS Acute Care NT-Probnp Testpak, Model CpbnpmDade Behring, Inc.200702