Data / Medical devices / United Kingdom / Lifescan Scotland Ltd
Lifescan Scotland Ltd: FDA-registered device maker in INVERNESS Highland, United Kingdom, 2 510(k) clearances
Lifescan Scotland Ltd is registered with the FDA (registration 3001058982) in INVERNESS Highland, United Kingdom. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 10, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001058982
- Address
- Beechwood Park North, INVERNESS Highland, United Kingdom, IV2 3ED
- Owner or operator
- Lifescan Scotland Ltd. (9026104)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- One Touch Ultra 2 Blood Glucose Monitoring System, One Touch Ultra 2 Meter, One Touch Ultra Mini Blood Glucose Monitoring System, OneTouch Delica Lancing Device and Lancets, OneTouch Delica Plus Lancing Device and Lancets, OneTouch Delica Safety Lancing Device and Lancets, OneTouch FinePoint Lancets, OneTouch Lancing Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Contract manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment, Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| February 10, 2011 | K103553 | LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION | JJX | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
| December 17, 2008 | K082590 | SYMPHONY METER REMOTE | LZG | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Glucose Dehydrogenase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Pump, Infusion, Insulin
Updated February 10, 2011. 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.