MICROLET®NEXT 2 Lancing Device— 510(k) K250813
Substantially EquivalentAscensia Diabetes Care U.S., Inc.
FDA 510(k) clearance K250813 for MICROLET®NEXT 2 Lancing Device, Substantially Equivalent on 2025-05-14. Applicant: Ascensia Diabetes Care U.S., Inc.. Device class: 2.
Clearance details
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- Product code
- Code QRL
- Device class
- Class 2
- Regulation
- 21 CFR 878.4850
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
Recent devices under product code QRL
view allMore clearances from Ascensia Diabetes Care U.S., Inc.
view all- K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K241810 — MICROLET®NEXT Lancet
- K223293 — CONTOUR® NEXT GEN Blood Glucose Monitoring System
- K220633 — MICROLET NEXT lancing device, MICROLET Lancet
- K162336 — Contour Next EZ Blood Glucose Monitoring System
Adverse events under product code QRL
product code QRL- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.