510(k) K021827 ยท NBW System, Test, Blood Glucose, Over The Counter
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 3, 2002 |
| Received | Jun 4, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021827
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.