510(k) K201630 ยท DJG Enzyme Immunoassay, Opiates
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
| Applicant | Assure Tech. (Hangzhou) Co, Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 12, 2021 |
| Received | Jun 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201630
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.