510(k) K133968 ยท DKZ Enzyme Immunoassay, Amphetamine
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Feb 25, 2014 |
| Received | Dec 26, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133968
| 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.