510(k) K152025 ยท DJR Enzyme Immunoassay, Methadone
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
| Applicant | Assure Tech. Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Oct 5, 2015 |
| Received | Jul 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152025
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.