510(k) K010362 ยท LFR Glucose Dehydrogenase, Glucose
ACCU-CHEK COMFORT CURVE TEST STRIP
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 7, 2001 |
| Received | Feb 6, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010362
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2006 | Roche Diagnostics Corp. Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. Terminated |
LFR | None listed |
| Feb 28, 2006 | Roche Diagnostics Corp. Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States). Terminated |
LFR | None listed |
| Feb 28, 2006 | Roche Diagnostics Corp. Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 03261964170, 03146154192, 03146146192, 03374700023, 03374718023, 11895133192, 11895141192, 03522091016, 03051161003, Terminated |
LFR | None listed |
| Feb 28, 2006 | Roche Diagnostics Corp. Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 03360652080, 03051188003, 03620115003 and 04535235003 (All sold outside of the United States). Terminated |
LFR | None listed |
| Feb 28, 2006 | Roche Diagnostics Corp. Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States). Terminated |
LFR | None listed |
| Apr 9, 2003 | Roche Diagnostics Corp. Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.