K250813
- 510(k) number
- K250813
- Device name
- MICROLET®NEXT 2 Lancing Device
- Applicant
- Ascensia Diabetes Care U.S., Inc. NJ · US
- Product code
- QRL — Multiple Use Blood Lancet For Single Patient Use Onl
- Decision date
- 2025-05-14
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250813.pdf
Official FDA record: K250813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.