CONTOUR® NEXT GEN Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Ascensia Diabetes Care US Inc.

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

Pre-market Notification Details

• Device ID: K223293
• 510k Number: K223293
• Device Name: CONTOUR® NEXT GEN Blood Glucose Monitoring System
• Classification: System, Test, Blood Glucose, Over The Counter
• Applicant: Ascensia Diabetes Care US Inc. 100 Summit Lake Drive Valhalla, NY 10595
• Contact: Larnie James
• Correspondent: Larnie James; Ascensia Diabetes Care US Inc. 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: 2022-10-26
• Decision Date: 2022-11-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40301939732016	K223293	000
40301937922013	K223293	000