510(k) Report

Devices descending from K010496

10 later devices reach Cedia Dau Amphetamines/Ecstasy Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012110Dri Ecstasy Enzyme ImmunoassayMicrogenics Corp.20019—
+2K240670DRI Ecstasy Plus AssayMicrogenics Corporation20240—
+2K043028Emit II Plus Ecstasy AssayDade Behring, Inc.20056—
+2K033094Ecstasy Enzyme Immunoassay, Catalog # 0160 (500 Test Kit), Catalog # 0161 (5000 Test Kit)Lin-Zhi International, Inc.20030—
+3K102779Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level…Siemens Healthcare Diagnostics, Inc.201112
+3K062182Dimension Vista System Ecstasy Calibrator, Model KC520Dade Behring, Inc.20060—
+3K053337Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109Dade Behring, Inc.20062—
+4K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine…Immunalysis Corporation20150—
+4K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+5K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103