510(k) Report

Devices descending from K053110

2 later devices reach Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.20181—
+2K200107epoc Blood Analysis SystemEpocal, Inc.2020019