510(k) Report

Devices descending from K024350

1 later device reach Acon H. Pylori Rapid Test Strip and Acon H. Pylori Rapid Test Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151935Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood…Alere San Diego, Incorporated20150—