Glucometer Elite Xl Blood Glucose Meter
by Bayer Corp.
510(k) K990649
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990649 | Date9 Jul 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Glucometer Elite Xl Blood Glucose Meter, Glucometer Elite Blood Glucose Test Systems
- 510(k) Number
- FDA Product Code
- CGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Glucometer Elite Xl Blood Glucose Meter is a blood glucose monitoring system for diabetes management in home or professional use. The system is based on electrode sensor technology. It is designed to monitor blood glucose levels. The device is a type of glucose oxidase, glucose device.
The Glucometer Elite Xl Blood Glucose Meter is supplied with a user manual and is intended for use with Glucometer Elite Test Strips. The device is regulated under product code CGA and regulation number 862.1345. It has been cleared by the FDA under the traditional clearance type with the decision code SESE.
Other devices from Bayer Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Glucometer Elite XL used for?
The Glucometer Elite XL is used for diabetes management, specifically to monitor blood glucose levels in home or professional settings.
What technology does the Glucometer Elite XL use?
The Glucometer Elite XL uses electrode sensor technology to monitor blood glucose levels.
What are the Glucometer Elite XL test strips compatible with?
The Glucometer Elite XL is intended for use with Glucometer Elite Test Strips.