510(k) Report

Devices descending from K003209

2 later devices reach Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog NO. DF93A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+2K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103