Glucose Range Monitoring System
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Basic Information
- Product Code
- SFU
- Device Class
- FDA class 2
- Regulation Number
- 862.1359
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240080 | Biolinq Shine Autonomous Time-in-Range Microsensor | Sep 23, 2025 | Unknown | Biolinq Incorporated |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.