510(k) Report

Devices descending from K991747

2 later devices reach Quickvue One-Step H. Pylori II Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024350Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test DeviceACON Laboratories, Inc.20031—
+2K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…Alere San Diego, Incorporated20150—