Data / Medical devices / Ireland / Abbott Ireland Diabetes Care
Abbott Ireland Diabetes Care: FDA-registered device maker in Donegal Town, Ireland, 4 510(k) clearances
Abbott Ireland Diabetes Care is registered with the FDA (registration 3007031103) in Donegal Town, Ireland. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 17, 2015. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007031103
- Address
- Donegal Town, Co. Donegal, Donegal Town, Ireland, Donegal
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer
- First device listed
- June 28, 2010
- Registered through
- 2027
- Brand names listed
- FreeStyle Blood Glucose Test Strips, FreeStyle Freedom Lite Blood Glucose Monitoring System, FreeStyle InsuLinx Blood Glucose Monitoring System, FreeStyle Lite Blood Glucose Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 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 |
|---|---|---|---|---|---|---|
| September 17, 2015 | K152328 | FreeStyle InsuLinx Blood Glucose Monotioring System | LFR | Substantially Equivalent | Abott Laboratories | accessdata.fda.gov |
| June 5, 2015 | K150531 | FreeStyle Freedom Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 5, 2015 | K150332 | FreeStyle Lite Blood Glucose Monitoring System | NBW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 15, 2010 | K092638 | FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 | NBW | Substantially Equivalent | Abbott Diabetes Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Dehydrogenase, Glucose
Updated September 17, 2015. 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.