Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
QDL is the FDA product code for Integrated Continuous Glucose Monitoring System For Professional Retrospective Use, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QDL
- Device name
- Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
- FDA definition
- An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.
- Regulation
- 21 CFR 862.1355
- 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
- 1
- Ingested recalls
- 0
Clearances, product code QDL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
Applicants with the most clearances
Product code QDL| Applicant | Clearances |
|---|---|
| Dexcom, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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