510(k) K223815 ยท QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
ONE DROP Lancing Device
| Applicant | Stat Medical Devices, North Miami Beach FL, US |
| Decision | Substantially Equivalent, Feb 15, 2023 |
| Received | Dec 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223815
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.