510(k) K031388 ยท CGA Glucose Oxidase, Glucose
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Hypoguard USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, May 22, 2003 |
| Received | May 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031388
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.