CONTOUR® NEXT ONE Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Ascensia Diabetes Care

The following data is part of a premarket notification filed by Ascensia Diabetes Care with the FDA for Contour® Next One Blood Glucose Monitoring System.

Pre-market Notification Details

• Device ID: K210687
• 510k Number: K210687
• Device Name: CONTOUR® NEXT ONE Blood Glucose Monitoring System
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Contact: Stacie Geffner-atiya
• Correspondent: Stacie Geffner-atiya; Ascensia Diabetes Care 100 Summit Lake Drive Valhalla, NY 10595
• Product Code: NBW
• CFR Regulation Number: 862.1345 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-08
• Decision Date: 2021-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40301937825017	K210687	000
40301939550016	K210687	000
40301937828018	K210687	000