The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Silica Clotting Time.
| Device ID | K160445 |
| 510k Number | K160445 |
| Device Name: | HemosIL Silica Clotting Time |
| Classification | Activated Partial Thromboplastin |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2442 |
| Contact | Heather L Harvey |
| Correspondent | Heather L Harvey INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2442 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-17 |
| Decision Date | 2016-03-16 |
| Summary: | summary |