510(k) K151211 ยท DIS Enzyme Immunoassay, Barbiturate
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup
| Applicant | Assure Tech. Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Jun 4, 2015 |
| Received | May 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151211
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.