510(k) K160944 ยท NBW System, Test, Blood Glucose, Over The Counter
ACCU-CHEK Guide Blood Glucose Monitoring System
| Applicant | Roche Diabetes Care, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | Apr 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160944
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2024 | Roche Diabetes Care, Inc. Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control Open, Classified |
NBW | None listed |
| Dec 30, 2019 | Roche Diabetes Care, Inc. Blood Glucose Monitoring System, Model Number 07400870001
ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure gl Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.