COAGUCHEK XS PLUS SYSTEM
FDA 510(k) clearance K071041 · decided 2007-05-11
Clearance details
- K-number
- K071041
- Device name
- COAGUCHEK XS PLUS SYSTEM
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2007-04-12
- Decision date
- 2007-05-11
- Days to decision
- 29 days
- Clearance type
- Special
- 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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| Record | Firm | Date |
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| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
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| STA- NeoPTimal (K211485) | Diagnostica Stago S.A.S | 2022-12-23 |
| Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) | Coagusense, Inc. | 2022-10-05 |
| HemosIL ReadiPlasTin (K213426) | Instrumentation Laboratory CO | 2022-08-16 |
| microINR System (K201185) | Iline Microsystems, S.L. | 2020-12-18 |
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| microINR System (K180780) | Iline Microsystems, S.L. | 2019-01-25 |
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 Plus System The CoaguChek XS Plus system for use by professional healthcare p recall (Z-1583-2013) | Roche Diagnostics Operations, Inc. | 2013-06-24 |
| Roche CoaguChek XS System, CoaguChek XS Plus Care Kit, Roche Diagnostics, Indianapolis, IN recall (Z-2004-2009) | Roche Diagnostics Operations, inc. | 2009-09-03 |
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 |