K912679 is an FDA 510(k) clearance for the DADE(R) IMMUNOADSORBED FACT V DEF 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 September 10, 1991, 84 days after receiving the submission on June 18, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K912679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1991 |
| Decision Date | September 10, 1991 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GJT — Plasma, Coagulation Factor Deficient |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |