510(k) K093460 ยท GJS Test, Time, Prothrombin
COAGUCHEK XS PRO SYSTEM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 18, 2010 |
| Received | Nov 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093460
| 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 Pro System
The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood fr Terminated |
GJS | None listed |
| Apr 15, 2013 | Roche Diagnostics Operations, Inc. CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner.
Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT"). Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.