510(k) K062925 ยท GJS Test, Time, Prothrombin
COAGUCHEK XS SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 29, 2007 |
| Received | Sep 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2021 | Roche Diagnostics Operations, Inc. CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin.
Catalog 04837738001 Terminated |
GJS | None listed |
| Jun 24, 2013 | Roche Diagnostics Operations, Inc. CoaguChek XS System (PST)
The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medicatio Terminated |
GJS | None listed |
| Sep 3, 2009 | Roche Diagnostics Operations, inc. Roche CoaguChek XS System, CoaguChek XS PST Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837738001.
CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring d Terminated |
GJS | None listed |
| Aug 11, 2009 | Roche Diagnostics Corp. Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indian Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.