510(k) Report

Devices descending from K042362

3 later devices reach Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140248S Test Reagent Cartridge Carbon Dioxide (CO2)Hitachi Chemical Diagnostics, Inc.20140—
+1K100289Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781Siemens Healthcare Diagnostics20101—
+2K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.20160—