510(k) K071041 ยท GJS Test, Time, Prothrombin
COAGUCHEK XS PLUS SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, May 11, 2007 |
| Received | Apr 12, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071041
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2018 | Roche Diagnostics Corporation CoaguChek XS System Prothrombin time test:
CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;
CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160;
CoaguChek XS PT Test 24 Tests, Cat Terminated |
GJS | None listed |
| Jun 24, 2013 | Roche Diagnostics Operations, Inc. CoaguChek XS Plus System
The CoaguChek XS Plus system 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 Plus Care Kit, Roche Diagnostics, Indianapolis, IN; Model Number 05021537001.
CoaguChek XS System and CoaguChek XS Plus System are point of care monitoring dev Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.