510(k) Report

Devices descending from K093297

2 later devices reach Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary Tube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200107epoc Blood Analysis SystemEpocal, Inc.2020019
+1K200492i-STAT CG4+ Cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.20200—