510(k) K043474 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK AVIVA SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 27, 2005 |
| Received | Dec 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043474
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number 04422058164; - Nordics Catalog number 04422040170. (Distributed outside of the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed outside of the U.S.) Terminated |
LFR | None listed |
| Jan 24, 2006 | Roche Diagnostics Corp. Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.) Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.