microINR System
FDA 510(k) clearance K180780 · decided 2019-01-25
Clearance details
- K-number
- K180780
- Device name
- microINR System
- Applicant
- Iline Microsystems, S.L.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-26
- Decision date
- 2019-01-25
- Days to decision
- 305 days
- Clearance type
- Traditional
- Product code
- GJS
- Device class
- 2
- Regulation number
- 864.7750
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Donostia-San Sebastian, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
| microINR System (K251564) | Iline Microsystems, S.L. | 2025-07-21 |
| microINR System (K243543) | Iline Microsystems, S.L. | 2025-02-27 |
| Xprecia Prime Coagulation System (K230802) | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| microINR System (K231711) | Iline Microsystems, S.L. | 2023-07-11 |
| 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 |
| Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (K183255) | Coagusense, Inc. | 2019-02-21 |
| CoaguChek XS Plus System (K180684) | Roche Diagnostics | 2018-04-19 |
Recalls involving this device
No recalls on record reference this clearance.