COAGUCHEK XS PRO SYSTEM
FDA 510(k) clearance K093460 · decided 2010-03-18
Clearance details
- K-number
- K093460
- Device name
- COAGUCHEK XS PRO SYSTEM
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2009-11-06
- Decision date
- 2010-03-18
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Numbe recall (Z-0360-2019) | Roche Diagnostics Corporation | 2018-11-02 |
| CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek recall (Z-1582-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCH recall (Z-1114-2013) | Roche Diagnostics Operations, Inc. | 2013-04-15 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |