Data / Medical devices / United States / LifeScan U.S. LLC
LifeScan U.S. LLC: FDA-registered device maker in Malvern, PA, United States, 5 510(k) clearances
LifeScan U.S. LLC is registered with the FDA (registration 3042301847) in Malvern, PA, United States. It lists 3 device types. The FDA files 5 510(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
- 3042301847
- Address
- 75 Valley Stream Pkwy, Malvern, PA, United States, 19355
- Owner or operator
- LifeScan U.S. LLC (10094560)
- Roles
- Specification developer
- First device listed
- February 23, 2026
- Registered through
- 2026
- Brand names listed
- OneTouch Select Blood Glucose Meter, OneTouch Select Blood Glucose Monitoring System, OneTouch Select Control Solutions, OneTouch Select Test Strips, OneTouch Ultra 2 Blood Glucose Monitoring System, OneTouch Ultra 2 Meter, OneTouch Ultra Blue Test Strips, OneTouch Ultra Control Solutions and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Oxidase, Glucose | CGA | 2 | Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Specification developer | 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 |
| October 5, 2007 | K072543 | ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| May 19, 2006 | K061118 | ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| January 17, 2006 | K053529 | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
| May 20, 2005 | K043197 | ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Lifescan, Inc. | accessdata.fda.gov |
Compare with other makers
- 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)
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.