510(k) K181768 ยท NFT Test, Amphetamine, Over The Counter
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
| Applicant | Assure Tech. (Hangzhou) Co, Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Aug 20, 2018 |
| Received | Jul 3, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181768
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.