510(k) Report

Devices descending from K181012

3 later devices reach BUHLMANN fCAL ELISA through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190784BUHLMANN fCAL turboBuhlmann Laboratories AG20192—
+2K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG20191—
+3K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG20240—