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FDA 510(k)

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

K-Number: K240287 · 2025-03-18

ApplicantHangzhou Laihe Biotech Co., Ltd.
Decision Date2025-03-18
Product CodeDJC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a medical device manufactured by Hangzhou Laihe Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-03-18 under approval number K240287. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Hangzhou Laihe Biotech Co., Ltd.. The 510(k) number is K240287.

When was LYHER® Oral fluid Multi-Drug Test Kit (Cube) approved by the FDA?

LYHER® Oral fluid Multi-Drug Test Kit (Cube) received FDA 510(k) clearance on 2025-03-18, under approval number K240287.

What company makes LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

LYHER® Oral fluid Multi-Drug Test Kit (Cube) is manufactured by Hangzhou Laihe Biotech Co., Ltd..

What is the FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube)?

The FDA product code for LYHER® Oral fluid Multi-Drug Test Kit (Cube) is DJC.

Related Clinical Trials

NCT07042620 A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery ACTIVE_NOT_RECRUITING NCT05081128 Efficacy in iNPH Shunting (PENS) Trial ACTIVE_NOT_RECRUITING NCT07442903 TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure RECRUITING NCT06201429 A Multi-center, Early Feasibility Study of Using the Mechanical Tissue Resuscitation™ (MTR®) Therapy System for Removal of Excess Fluid in Subjects Who Have Had a Portion of Their Skull Removed to Expose the Dura/Brain and Require Drainage for Fluid Removal. RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING NCT05011656 Blood Purification for the Treatment of Pathogen Associated Shock ACTIVE_NOT_RECRUITING

Other Devices by Hangzhou Laihe Biotech Co., Ltd.

K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

Related Devices (Code: DJC)

K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd. K180878BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for RxShanghai Venture Bio-Tech Co., Ltd. K181305OralTox Oral fluid Drug TestPremier Biotech, Inc. K171403OralTox Oral Fluid Drug TestPremier Biotech, Inc. K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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