LDJ — Enzyme Immunoassay, Cannabinoids Class II

FDA Device Classification

Classification Details

Product Code
LDJ
Device Class
Class II
Regulation Number
862.3870
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232732co-innovation biotech coRapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, RapiJanuary 17, 2024
K232604hangzhou laihe biotech coLYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) TestJanuary 10, 2024
K223162healgen scientificHealgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test CMarch 17, 2023
K192515shenzhen bioeasy biotechnology coBIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY October 11, 2019
K153741hangzhou clongene biotech coCLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestMarch 18, 2016
K152643nantong egens biotech coEGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine TeNovember 2, 2015
K151203immunalysis corporationImmunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine CalibrJune 5, 2015
K141320lin-zhi internationalLZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids CaliMay 28, 2015
K142408polymed therapeuticsFaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStepSeptember 25, 2014
K140546healgen scientificHEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTJune 6, 2014
K130213lumiquick diagnosticsQUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE October 18, 2013
K132096biophor diagnosticsRAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOctober 18, 2013
K122633branan medicalTOXCUP DRUG SCREEN CUPFebruary 7, 2013
K122759omega laboratoriesOMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)December 5, 2012
K121557guangzhou wondfo biotech coWONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTJuly 25, 2012
K111929psychemedicsPSYCHEMEDICS CANNABINOIDS EIAMay 1, 2012
K102428hien helen nguyenWUNDER TESTApril 18, 2012
K110239lin-zhi internationalLZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLJune 23, 2011
K110182guangzhou wondfo biotech coCANNABINOIDS URINE TESTMay 20, 2011
K101744microgenicsTHERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAYApril 8, 2011