Wondfo T-Cup Multi-Drug Urine Test Cup
FDA 510(k) clearance K182701 · decided 2018-12-03
Clearance details
- K-number
- K182701
- Device name
- Wondfo T-Cup Multi-Drug Urine Test Cup
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-27
- Decision date
- 2018-12-03
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- NFT
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Guangzhou, CN
- 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 |