K160445 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 CO (Bedford, US). The FDA issued a Cleared decision on March 16, 2016, 28 days after receiving the submission on February 17, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K160445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2016 |
| Decision Date | March 16, 2016 |
| Days to Decision | 28 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 |