510(k) K060978 ยท GJS Test, Time, Prothrombin
COAGUCHEK XS SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 11, 2006 |
| Received | Apr 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2021 | Roche Diagnostics Operations, Inc. CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Catalog: 04837975001
Units could cons Terminated |
GJS | None listed |
| Jun 24, 2013 | Roche Diagnostics Operations, Inc. CoaguChek XS System (HCP)
The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Terminated |
GJS | None listed |
| Sep 3, 2009 | Roche Diagnostics Operations, inc. Roche CoaguChek XS System, CoaguChek XS Professional Care Kit, Roche Diagnostics, Indianapolis, IN; Catalog/Model Number 04837975001.
CoaguChek XS System and CoaguChek XS Plus System are point of ca Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.