510(k) Report

Devices descending from K031512

4 later devices reach Emit II Plus Cocaine Metabolite Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062123Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.200601
+1K033713Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ADade Behring, Inc.20042—
+2K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+3K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103