510(k) Report

Devices descending from K993755

8 later devices reach Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062162Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)Dade Behring, Inc.20060—
+1K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.200563
+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—