510(k) K122961 ยท DKZ Enzyme Immunoassay, Amphetamine
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Dec 21, 2012 |
| Received | Sep 25, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122961
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.