510(k) K012210 ยท NBW System, Test, Blood Glucose, Over The Counter
MODIFICATION TO ACCU-CHEK INFORM METER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 9, 2001 |
| Received | Jul 16, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012210
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 28, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform meter; catalog No. 3035123. Terminated |
NBW | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform meter; catalog No. 3035123. Terminated |
NBW | None listed |
| Jul 20, 2004 | Roche Diagnostics Corp. ACCU-CHEK Inform base unit; catalog no. 3035131. Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.