510(k) K232488 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Accu-Chek Safe-T-Pro Plus Lancing Device
| Applicant | Roche Diabetes Care, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 13, 2023 |
| Received | Aug 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232488
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.