LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)— 510(k) K232604

Name: FDA 510(k) clearance K232604
Creator: U.S. Food and Drug Administration
Published: 2024-01-10

Substantially Equivalent

Hangzhou Laihe Biotech Co., Ltd.

FDA 510(k) clearance K232604 for LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette), Substantially Equivalent on 2024-01-10. Applicant: Hangzhou Laihe Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Laihe Biotech Co., Ltd.
Product code: Code LDJ
Device class: Class 2
Regulation: 21 CFR 862.3870
Advisory panel: Clinical Toxicology
Date received: 2023-08-28
Decision date: 2024-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.