510(k) K191038 ยท NBW System, Test, Blood Glucose, Over The Counter
On Call Express Voice Blood Glucose Monitoring System
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 12, 2019 |
| Received | Apr 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191038
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.