510(k) K250085 · NBW System, Test, Blood Glucose, Over The Counter
On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 10, 2025 |
| Received | Jan 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250085
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.