510(k) K130138 ยท NBW System, Test, Blood Glucose, Over The Counter
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 15, 2013 |
| Received | Jan 18, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130138
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.