510(k) K221175 ยท QRL Multiple Use Blood Lancet For Single Patient Use Only
Multi-Lancet Device 2, ReliOn Premier Lancing Device
| Applicant | Arkray, Inc., Kyoto, JP |
| Decision | Substantially Equivalent, Oct 17, 2022 |
| Received | Apr 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221175
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.