510(k) K150910 ยท NDC Calculator, Drug Dose
ACCU-CHEK Connect Diabetes Management App
| Applicant | Roche Diabetes Care, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 3, 2015 |
| Received | Apr 3, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2019 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | None listed |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017
The Accu-Chek Connect Diabetes Mana Terminated |
NDC | None listed |
| Jun 8, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 Terminated |
NDC | None listed |
| Mar 14, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Product Usage:
This is a digital product available for download direct to customers from the Apple App St Terminated |
NDC | None listed |
| Jan 26, 2017 | Roche Diabetes Care, Inc. Accu-Chek Connect Diabetes Management App Terminated |
NDC | None listed |
| Nov 16, 2016 | Roche Diabetes Care, Inc. Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Terminated |
NDC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.