510(k) K043197 ยท CGA Glucose Oxidase, Glucose
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, May 20, 2005 |
| Received | Nov 18, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2006 | Lifescan Inc LifeScan OneTouch Ultra Test strips, lot number 2528640 Terminated |
CGA | None listed |
| Dec 8, 2005 | Lifescan Inc LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter Terminated |
NBW | None listed |
| Dec 8, 2005 | Lifescan Inc LifeScan brand OneTouch Ultra Test strips, 25 strips per vial Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.