K260551 is an FDA 510(k) clearance for the HemosIL Factor V Leiden (APC Resistance V). This device is classified as a Test, Time, Partial Thromboplastin (Class II - Special Controls, product code GGW).
Submitted by Instrumentation Laboratory (IL) Co. (Bedford, US). The FDA issued a Cleared decision on March 20, 2026, 30 days after receiving the submission on February 18, 2026.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K260551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2026 |
| Decision Date | March 20, 2026 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGW — Test, Time, Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |