510(k) K053529 ยท NBW System, Test, Blood Glucose, Over The Counter
ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Jan 17, 2006 |
| Received | Dec 19, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053529
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.