510(k) K994433 ยท LFR Glucose Dehydrogenase, Glucose
CONNECT DATA MANAGEMENT SYSTEM
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Dec 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2005 | Abbott Diabetes Care, Inc. FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.