510(k) K111353 ยท LZG Pump, Infusion, Insulin
ACCU-CHECK COMBO SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 17, 2012 |
| Received | May 16, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K111353
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. Terminated |
LZG | None listed |
| Oct 29, 2014 | Roche Diagnostics Operations, Inc. ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System
Product Usage:
The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for scre Terminated |
LZG | None listed |
| Nov 22, 2013 | Roche Diagnostics Operations, Inc. ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\
The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantita Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.