The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Silica Clotting Time.
| Device ID | K050221 |
| 510k Number | K050221 |
| Device Name: | HEMOSIL SILICA CLOTTING TIME |
| Classification | Activated Partial Thromboplastin |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-31 |
| Decision Date | 2005-03-30 |
| Summary: | summary |