510(k) K060620 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK AVIVA TEST STRIPS
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Mar 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3 Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.