The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade Immunoadsorbed Factor Ix Deficient Plasma.
| Device ID | K915411 |
| 510k Number | K915411 |
| Device Name: | DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA |
| Classification | Plasma, Coagulation Factor Deficient |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Alodia M Ruiz |
| Correspondent | Alodia M Ruiz BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | GJT |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-05-11 |