MICROLET®NEXT 2 Lancing Device
FDA 510(k) clearance K250813 · decided 2025-05-14
Clearance details
- K-number
- K250813
- Device name
- MICROLET®NEXT 2 Lancing Device
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-17
- Decision date
- 2025-05-14
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- QRL
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.