Cleared Traditional

LYHER? Urine Multi-Drug Test Kit(Cup), LYHER? Urine Multi-Drug Test Kit(Cassette), LYHER? Urine Multi-Drug Test Kit(Dipcard)

K232597 · Hangzhou Laihe Biotech Co., Ltd. · Toxicology

Jan 2024

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K232597 is an FDA 510(k) clearance for the LYHER? Urine Multi-Drug Test Kit(Cup), LYHER? Urine Multi-Drug Test Kit(Cassette), LYHER? Urine Multi-Drug Test Kit(Dipcard), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Hangzhou Laihe Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 9, 2024, 134 days after receiving the submission on August 28, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number	K232597 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2023
Decision Date	January 09, 2024
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF