510(k) K222656 ยท QRL Multiple Use Blood Lancet For Single Patient Use Only
LDE4 Lancing Device
| Applicant | I-Sens, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 23, 2022 |
| Received | Sep 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222656
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.