510(k) K192987 ยท LCP Assay, Glycosylated Hemoglobin
Aina HbA1c Monitoring System 2
| Applicant | Jana Care, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Mar 26, 2020 |
| Received | Oct 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192987
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.