510(k) K021819 ยท NBW System, Test, Blood Glucose, Over The Counter
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Aug 23, 2002 |
| Received | Jun 4, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2005 | Lifescan Inc LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A;
All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Co Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.