LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)— 510(k) K232597

Name: FDA 510(k) clearance K232597
Creator: U.S. Food and Drug Administration
Published: 2024-01-09

Substantially Equivalent

Hangzhou Laihe Biotech Co., Ltd.

FDA 510(k) clearance K232597 for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard), Substantially Equivalent on 2024-01-09. Applicant: Hangzhou Laihe Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hangzhou Laihe Biotech Co., Ltd.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-08-28
Decision date: 2024-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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