510(k) Report

Devices descending from K932113

7 later devices reach Cannabinoid Urine Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021449Cannabinoid Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.200251
+1K971210Synchron Systems 10 NG/ML & 40 NG/ML THC Urine ControlsBeckman Instruments, Inc.19970—
+2K110239Lzi Cannabinoids (CTHC) Homogeneous Enzyme Immunoassay, Calibrators, ControlLin-Zhi International, Inc.20114—
+3K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…Immunalysis Corporation20150—
+3K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…Lin-Zhi International, Inc.20152—
+4K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC20231—
+5K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC20260—