510(k) Report

Devices descending from K010960

2 later devices reach Emit II Plus Ethyl Alcohol Assay, Model OSR9K229 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071811Etoh Flex Reagent Cartridge (DF22)Dade Behring, Inc.200701
+1K070853Dimension Vista Etoh Flex Reagent Cartridge, Model K5022Dade Behring, Inc.20070—