MICROLET®NEXT Lancet— 510(k) K241810
Substantially EquivalentAscensia Diabetes Care U.S., Inc.
FDA 510(k) clearance K241810 for MICROLET®NEXT Lancet, Substantially Equivalent on 2024-08-15. Applicant: Ascensia Diabetes Care U.S., Inc.. Device class: 2.
Clearance details
- Applicant
- Ascensia Diabetes Care U.S., Inc.
- Product code
- Code QRK
- 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 QRK
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Data sourced from openFDA. This site is unofficial and independent of the FDA.