K820835 is an FDA 510(k) clearance for the ALUMINA SILICA-ACTIVATED PARTIAL THROM. This device is classified as a Activated Partial Thromboplastin (Class II - Special Controls, product code GFO).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982, 31 days after receiving the submission on March 26, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K820835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1982 |
| Decision Date | April 26, 1982 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GFO — Activated Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |