510(k) K250813 · QRL Multiple Use Blood Lancet For Single Patient Use Only
MICROLET®NEXT 2 Lancing Device
| Applicant | Ascensia Diabetes Care U.S., Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, May 14, 2025 |
| Received | Mar 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250813
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.