FDA.reportPublic FDA data

510(k) K232604

Device
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
Applicant
Hangzhou Laihe Biotech Co., Ltd.
510(k) number
K232604
Product code
LDJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-10
Date received
2023-08-28
Regulation
862.3870
Classification name
Enzyme Immunoassay, Cannabinoids
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yaohua Chen
Address
Rm. 401-406, F1-3, Bldg. 1, #425 Miaohouwang Rd. Xixing St., Binjiang District Hangzhou CN 310051 310051

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LDJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.2024-01-17
K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLC2023-03-17
K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20Shenzhen Bioeasy Biotechnology Co., Ltd.2019-10-11
K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.2016-03-18
K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette MarijuanaNantong Egens Biotech Co., Ltd.2015-11-02
K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control SetImmunalysis Corporation2015-06-05
K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids ControlsLin-Zhi International, Inc.2015-05-28
K142408FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Polymed Therapeutics, Inc.2014-09-25
K140546HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TESTHealgen Scientific,, LLC2014-06-06
K132096RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTORBiophor Diagnostics, Inc.2013-10-18
K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELumiquick Diagnostics, Inc.2013-10-18
K122633TOXCUP DRUG SCREEN CUPBranan Medical Corp.2013-02-07
K122759OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)Omega Laboratories, Inc.2012-12-05
K121557WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TESTGuangzhou Wondfo Biotech Co., Ltd.2012-07-25
K111929PSYCHEMEDICS CANNABINOIDS EIAPsychemedics Corp.2012-05-01