510(k) Report

Devices descending from K993982

6 later devices reach Syva Emit II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031004Syva Emit II Plus Amphetamines AssayDade Behring, Inc.20035—
+2K062077Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…Ortho-Clinical Diagnostics, Inc.200615
+2K040133Urine Amphetamine/Methamphetamine Screen Flex Reagent CartridgeDade Behring, Inc.20042—
+3K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation20150—
+3K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+4K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103