510(k) K213131 ยท NBW System, Test, Blood Glucose, Over The Counter
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
| Applicant | Roche Diabetes Care GmbH, Mannheim, DE |
| Decision | Substantially Equivalent, Aug 10, 2023 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213131
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.