510(k) Report

Devices descending from K011566

3 later devices reach Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc.20140—
+1K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…Bio-Rad Laboratories, Inc.20130—
+1K073145Quanta Lite H-TTG ScreenInova Diagnostics, Inc.20080—