510(k) Report

Devices descending from K993988

6 later devices reach Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.20170—
+1K031512Emit II Plus Cocaine Metabolite AssayDade Behring, Inc.20034—
+2K062123Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…Ortho-Clinical Diagnostics, Inc.200601
+2K033713Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92ADade Behring, Inc.20042—
+3K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+4K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103