510(k) K040796 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK GO SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 22, 2004 |
| Received | Mar 29, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Roche Diagnostics Corp. Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Dia Terminated |
LFR | None listed |
| Aug 13, 2005 | Roche Diagnostics Corp. ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter. Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.