510(k) K182738 ยท DKZ Enzyme Immunoassay, Amphetamine
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Te
| Applicant | Hangzhou AllTest Biotech Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Mar 27, 2019 |
| Received | Sep 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182738
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.