510(k) K141532 ยท DKZ Enzyme Immunoassay, Amphetamine
CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jul 14, 2014 |
| Received | Jun 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141532
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.