510(k) K181131 ยท NBW System, Test, Blood Glucose, Over The Counter
Accu-Chek Guide Me Blood Glucose Monitoring System
| Applicant | Roche Diabetes Care, Indianapolis IN, US |
| Decision | Substantially Equivalent, Dec 13, 2018 |
| Received | Apr 30, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181131
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.