Data / Medical devices / Ireland / Abbott Ireland, ADC Kilkenny
Abbott Ireland, ADC Kilkenny: FDA-registered device maker in Kilkenny, Ireland, 2 510(k) clearances
Abbott Ireland, ADC Kilkenny is registered with the FDA (registration 3033394445) in Kilkenny, Ireland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 23, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033394445
- Address
- IDA Ireland Kilkenny Business & Technology Park Ring Road, Kilkenny, Ireland, R95 A02A
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- September 14, 2023
- Registered through
- 2027
- Brand names listed
- FreeStyle Libre 2 Flash Glucose Monitoring System, FreeStyle Libre 3 Continuous Glucose Monitoring System, Instinct sensor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | 2 | Manufacturer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | QLG | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2024 | K233537 | FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
| March 3, 2023 | K222447 | FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Updated April 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.