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510(k) K162336

Contour Next EZ Blood Glucose Monitoring System by Ascensia Diabetes Care U.S., Inc. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
August 22, 2016
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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  • K220633 — MICROLET NEXT lancing device, MICROLET Lancet (June 3, 2022)
  • K160430 — Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood G (June 24, 2016)

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  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)