Chrysalis Intelligence · Sponsors · Ascensia Diabetes Care U.S., Inc.

Ascensia Diabetes Care U.S., Inc.

Parsippany, NJ, US · 5 510(k) clearances

Total clearances
5
2022-06-03 → 2025-05-14
Last 12 months
0
Product codes
3
Most recent
2025-05-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QRL Multiple Use Blood Lancet For Single Patient Use Only Class II General, Plastic Surgery 2 2025-05-14
NBW System, Test, Blood Glucose, Over The Counter Class II Clinical Chemistry 2 2024-08-27
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 1 2024-08-15
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2025-05-14 K250813 MICROLET®NEXT 2 Lancing Device QRL Class II General, Plastic Surgery
2024-08-27 K241787 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2024-08-15 K241810 MICROLET®NEXT Lancet QRK Class II General, Plastic Surgery
2022-11-18 K223293 CONTOUR® NEXT GEN Blood Glucose Monitoring System NBW Class II Clinical Chemistry
2022-06-03 K220633 MICROLET NEXT lancing device, MICROLET Lancet QRL Class II General, Plastic Surgery