510(k) K024194 ยท NBW System, Test, Blood Glucose, Over The Counter
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Feb 7, 2003 |
| Received | Dec 20, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024194
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Meter - Owner''s Booklet;
Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037 Terminated |
NBW | None listed |
| Jun 14, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc.,
1000 Gibraltar Drive, Milpitas, CA 95037 Terminated |
CGA | None listed |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Blood Glucose Meter Terminated |
NBW | None listed |
| May 17, 2005 | Lifescan Inc LifeScan brand OneTouch FastTake Blood Glucose Meter Terminated |
NBW | None listed |
| May 17, 2005 | Lifescan Inc LifeScan Brand InDuo Blood Glucose Meter Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.