WONDFO MULTI-DRUG URINE TEST CUP, PANEL
FDA 510(k) clearance K133968 · decided 2014-02-25
Clearance details
- K-number
- K133968
- Device name
- WONDFO MULTI-DRUG URINE TEST CUP, PANEL
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-26
- Decision date
- 2014-02-25
- Days to decision
- 61 days
- Clearance type
- Special
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) U recall (Z-1589-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |