WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU— 510(k) K122904
Substantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.
FDA 510(k) clearance K122904 for WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU, Substantially Equivalent on 2012-11-15. Applicant: Guangzhou Wondfo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gaithersburg, MD, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.