LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassett…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232597

Identifiers

510(k) Number: K232597 FDA 510(k)
FDA Product Code: DJG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3650 FDA 510(k)
Regulation Number: 862.3650 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassett… by Hangzhou Laihe Biotech Co., Ltd. — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K232597	Class II	Active

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Manufacturer

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.

Sources (1)

FDA 510(k) K232597 24 fields · synced Jun 19, 2026