510(k) K020232 ยท CGA Glucose Oxidase, Glucose
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Hypoguard USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Feb 12, 2002 |
| Received | Jan 14, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 25, 2003 | Hypoguard USA, Inc. Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles. Terminated |
CGA | None listed |
| Dec 25, 2003 | Hypoguard USA, Inc. Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.