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SFUClass II

Glucose Range Monitoring System

21 CFR 862.1359 / Clinical Chemistry
FDA source (opens on fda.gov)

SFU is the FDA product code for Glucose Range Monitoring System, a class II device type, regulated under 21 CFR 862.1359. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFU
Device name
Glucose Range Monitoring System
FDA 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.
Regulation
21 CFR 862.1359
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code SFU

By decision year
2 clearances under product code SFU with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFU by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code SFU
Applicants holding the most 510(k) clearances under product code SFU
ApplicantClearances
Biolinq Incorporated1
Biolinq Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code