The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Alumina Silica-activated Partial Throm.
| Device ID | K820835 |
| 510k Number | K820835 |
| Device Name: | ALUMINA SILICA-ACTIVATED PARTIAL THROM |
| Classification | Activated Partial Thromboplastin |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-26 |
| Decision Date | 1982-04-26 |