510(k) Report

Devices descending from K983159

23 later devices reach Drugs of Abuse Urine Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.200563
+1K023316Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20020—
+1K020769Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20025—
+1K012109Dri Ecstasy Urine CalibratorsMicrogenics Corp.20018—
+2K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20160—
+2K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20160—
+2K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20150—
+2K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…Immunalysis Corporation20150—
+2K133710Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc.20140—
+2K132090Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine…Randox Laboratories, Ltd.20130—
+2K120761Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate…Lin-Zhi International, Inc.20122—
+2K113139Lzi Cocaine Metabolite Homogeneous Enzyme Immunoassay,Calibrators,ControlsLin-Zhi International, Inc.20111—
+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—
+3K191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DX20200—
+3K141803Immunalysis Tramadol Urine Enzyme ImmunoassayImmunalysis Corporation20151—
+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—
+4K203527Immunalysis Tapentadol Urine HEIALmmunalysis Corporation20220—
+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