510(k) Report

Devices descending from K051088

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20160—
+1K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20160—
+1K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation20150—
+1K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…Immunalysis Corporation20150—
+1K133710Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc.20140—
+1K132090Benzodiazepine Calibrator Set, Benzodiazepine Control Level 1, and Benzodiazepine…Randox Laboratories, Ltd.20130—