K880874 is an FDA 510(k) clearance for the IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN. This device is classified as a Plasma, Coagulation Factor Deficient (Class II - Special Controls, product code GJT).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on March 17, 1988, 16 days after receiving the submission on March 1, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K880874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1988 |
| Decision Date | March 17, 1988 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GJT — Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |