Product code SFU— Clinical Chemistry
Biolinq Shine Autonomous Time-in-Range Microsensor
- Classification name
- Glucose Range Monitoring System
- Device class
- Class 2
- Regulation
- 21 CFR 862.1359
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SFU
FDA has cleared device under product code SFU, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SFU
Recent clearances under product code SFU
Data sourced from openFDA. This site is unofficial and independent of the FDA.