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510(k) K223293

CONTOUR® NEXT GEN Blood Glucose Monitoring System by Ascensia Diabetes Care U.S., Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2022
Date Received
October 26, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Ascensia Diabetes Care U.S., Inc.

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  • K241810 — MICROLET®NEXT Lancet (August 15, 2024)
  • K220633 — MICROLET NEXT lancing device, MICROLET Lancet (June 3, 2022)
  • K162336 — Contour Next EZ Blood Glucose Monitoring System (January 12, 2017)
  • K160430 — Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood G (June 24, 2016)

Other clearances for product code NBW

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  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)