510(k) K011738 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK ACTIVE SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 20, 2001 |
| Received | Jun 5, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011738
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.