510(k) K984527 ยท CGA Glucose Oxidase, Glucose
IN TOUCH DIABETES MANAGEMENT SOFTWARE
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 29, 1999 |
| Received | Dec 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984527
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2008 | Lifescan Inc LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037. Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.