K243543 is an FDA 510(k) clearance for the microINR System. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Iline Microsystems, S.L. (San Sebastian-Donostia, ES). The FDA issued a Cleared decision on February 27, 2025, 104 days after receiving the submission on November 15, 2024.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K243543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2024 |
| Decision Date | February 27, 2025 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS - Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |