Cleared Traditional

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

K240287 · Hangzhou Laihe Biotech Co., Ltd. · Toxicology
Mar 2025
Decision
411d
Days
Class 2
Risk

About This 510(k) Submission

K240287 is an FDA 510(k) clearance for the LYHER? Oral fluid Multi-Drug Test Kit (Cube), a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Hangzhou Laihe Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 18, 2025, 411 days after receiving the submission on February 1, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K240287 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2024
Decision Date March 18, 2025
Days to Decision 411 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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