510(k) K070585 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK PERFORMA SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, May 25, 2007 |
| Received | Mar 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | None listed |
| Sep 16, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN.
Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.