510(k) Report

Devices descending from K133404

2 later devices reach Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB201611
+2K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.20240—