The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade Recomboplastin S.
| Device ID | K921326 |
| 510k Number | K921326 |
| Device Name: | DADE RECOMBOPLASTIN S |
| Classification | Test, Time, Prothrombin |
| 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 | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-18 |
| Decision Date | 1992-07-27 |