LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

FDA 510(k) K232604 · Hangzhou Laihe Biotech Co., Ltd.

Substantially Equivalent

510(k) numberK232604

Submission

Device name
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
Applicant
Hangzhou Laihe Biotech Co., Ltd.
Hangzhou, CN
Received
August 28, 2023
Decision date
January 10, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LDJ – Enzyme Immunoassay, Cannabinoids
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Specialty
Clinical Toxicology

Other 510(k)s with product code LDJ

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K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid…LDJ · Traditional Co-Innovation Biotech Co., Ltd.01/17/2024SE
K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional Healgen Scientific,, LLC03/17/2023SE
K192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional Shenzhen Bioeasy Biotechnology Co., Ltd.10/11/2019SE
K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional Hangzhou Clongene Biotech Co., Ltd.03/18/2016SE
K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional Nantong Egens Biotech Co., Ltd.11/02/2015SE
K151203Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional Immunalysis Corporation06/05/2015SE
K141320LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional Lin-Zhi International, Inc.05/28/2015SE
K142408FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional Polymed Therapeutics, Inc.09/25/2014SE
K140546Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional Healgen Scientific,, LLC06/06/2014SE
K132096Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorLDJ · Traditional Biophor Diagnostics, Inc.10/18/2013SE

More from Biophor Diagnostics, Inc.

510(k)DeviceDecision
K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional 03/18/2025SE
K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette)…DJG · Traditional 01/09/2024SE

Questions and answers

When was LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) cleared by the FDA?

LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) (K232604) received a 510(k) decision of Substantially Equivalent on January 10, 2024, 135 days after the submission was received.

What is the product code of K232604?

The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.