510(k) K053635 ยท NBW System, Test, Blood Glucose, Over The Counter
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Bionime Corporation, Great Neck NY, US |
| Decision | Substantially Equivalent, Feb 21, 2006 |
| Received | Dec 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2008 | Invictus Scientific Inc Invictus-- Bionime Rightest Blood Glucose Monitoring System
MODEL: GM300; Invictus Scientific, Inc., San Diego, CA Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.