510(k) Report

Devices descending from K161899

1 later device reach ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.20240—