510(k) K181527 ยท NBW System, Test, Blood Glucose, Over The Counter
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 3, 2018 |
| Received | Jun 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181527
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.