510(k) K183230 ยท LCP Assay, Glycosylated Hemoglobin
OneDraw A1C Test System
| Applicant | Drawbridge Health, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | Nov 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183230
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.