K253957 is an FDA 510(k) clearance for the HemosIL Silica Clotting Time. This device is classified as a Activated Partial Thromboplastin (Class II - Special Controls, product code GFO).
Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on January 9, 2026, 30 days after receiving the submission on December 10, 2025.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K253957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GFO — Activated Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |