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 |
Trademark Results [CONTOUR]
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