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Wondfo Multi-Drug Urine Test Cup Model W2002-Cu +7 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122904

by Guangzhou Wondfo Biotech Co., Ltd.

Identifiers

510(k) Number
K122904 FDA 510(k)
FDA Product Code
DKZ FDA 510(k)
Models / Variants
Wondfo Multi-Drug Urine Test Cup Model W2002-Cu FDA 510(k)
W2003-Cu FDA 510(k)
W2004-Cu FDA 510(k)
W2005-Cu FDA 510(k)
W2006-Cu FDA 510(k)
W2007-Cu FDA 510(k)
W2008-Cu FDA 510(k)
W2009-Cu FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Wondfo Multi-Drug Urine Test Cup Model W2002-Cu +7 more models by Guangzhou Wondfo Biotech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K122904 24 fields · synced Jun 18, 2026