510(k) K180209 ยท NOZ Assay, 1,5-Anhydroglucitol (15ag)
Diazyme 1,5-AG Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Oct 4, 2018 |
| Received | Jan 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180209
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.