510(k) K182701 ยท NFT Test, Amphetamine, Over The Counter
Wondfo T-Cup Multi-Drug Urine Test Cup
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Dec 3, 2018 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Drugs of Abuse Tests:
a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114.
b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug P Open, Classified |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.